Posts Tagged ‘clinical trials at emory’

New study uses cryoablation to reduce pain for cancer patients

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Kevin Makowski, RBP

A new study using cryoablation to decrease pain for patients who have cancer metastases in the bone is now underway throughout Emory Healthcare. Cryoablation is a process that uses extreme cold (cryo) to destroy or damage tissue (ablation).

Called the “Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases”, or MOTION, the study aims to assess the effectiveness and safety of cryoablation therapy to treat patients with painful bone metastases and document the effects the procedure has on their condition.

The prospective, single-arm study will enroll 60 participants at eight centers in the U.S. and internationally. Twenty participants can enroll at Emory Johns Creek Hospital, Emory University Hospital, Emory University Hospital Midtown, and Emory Saint Joseph’s Hospital. Participants will serve as their own control group in this one-year study.

The clinical trial examines self-reported pain scores from the patients. Investigators are assessing improvement in scores defined by more than a two-point reduction in the worst pain in the last 24 hours, using the Brief Pain Inventory (BPI), from before the cryoablation procedure to eight weeks after the procedure takes place. The trial will assess patients experiencing pain at a level of 4 or above on a scale of 0 (no pain) to 10 (unimaginable pain).

The goal is to freeze cancerous cells and stop the pain signals to the brain. We use image guidance to insert the ablation probe into the middle of a painful cancer lesion. Then, we create an ablation zone by lowering the temperature to minus 40 degrees centigrade for 10 minutes.

Emory interventional radiologists freeze tumors in order to kill cancer cells in contact with the bone and reduce the size of the tumor. CT images obtained during the procedure helps doctors guide needles into the tumor.

Cryoablation provides an alternative for patients who haven’t experienced relief from current pain therapies. Many patients suffering from cancer pain take several medications to cope with the pain.

The outpatient cryoablation procedure takes about an hour.

Galil Medical is funding this clinical trial.

For more information about this study, contact the study coordinator, Maria Rivas at 404-712-7962.

Learn more about other available trials.  http://clinicaltrials.emory.edu/

Dr. J. David Prologo

J. David Prologo, MDdavid_prologo_photo, is an assistant professor in the Department of Radiology and Imaging Sciences at Emory’s School of Medicine, and director of Interventional Radiology Services at EJCH. Prologo is the principal site investigator for the MOTION study, and one of 10 subspecialty trained, board certified interventional radiologists at Emory.

Healthy Participant Raises Awareness for Importance of Clinical Trials

cmv_brittanyBrittany Robinson of Suwanee, GA, recently spent eight days and nights at Emory University Hospital, but she was not sick. To some people, spending over a week away from her husband and five children may seem crazy, but for Brittany, it was a personal way to give back and say thank you to the hospital that helped her son, Ethan.

Ethan was diagnosed at birth with the heart defect Wolff-Parkinson-White (WPW) syndrome with Ebstein’s anomaly, and was treated at Emory-Children’s Center. “My son was on medication from nine months old until last year. If there wasn’t someone doing this for him, for his heart medication, who knows what would have happened,” said Robinson. The medicine prescribed to Ethan went through the same process rigorous clinical trials process that all new drugs must go through.

It was this realization that prompted Brittany to enroll in an in-patient research study (A Phase I Trial to Evaluate the Safety and Pharmacokinetics of Multiple Ascending Doses of MBX-400 in Healthy Volunteers), testing the oral medication MBX-400 to treat cytomegalovirus (CMV) infection.

CMV is a common virus that can infect the majority of the population but can cause severe eye, neurologic, and organ diseases in patients with a weakened immune system. The oral and IV medications currently used to treat CMV have limitations and many scientists are stepping up to help find a new treatment. The study’s enrollment criteria requires only healthy people can enroll.

Allison Beck, PA, Mari Hart, RN, Nadine Rouphael, MD, and a team of Research Coordinators with the Hope Clinic have been recruiting for months to fully enroll this trial. Their struggle is common for clinical trial recruitment. People are hesitant because they do not want to be a “guinea pig” or are too busy to interrupt their normal routine though most studies provide compensation for time and travel. Unfortunately, people like Brittany who’ve relied on the medical field to save their loved ones usually do not make the incredible connection she made. This study is still enrolling and only has half the participants needed to complete the trial.

“Without research, we do not have the treatments and cures that save our loved ones. New medicines and vaccines that work and are safe are only discovered when heroes like Brittany and her family are willing to give their time to research and enroll in a study,” said study PI Mark Mulligan, MD, distinguished professor, Department of Medicine and executive director, Hope Clinic of the Emory Vaccine Center, Emory University. While Brittany may never know anyone with CMV, she is helping to give better treatments to those who are ill.

Every medication, treatment, or medical device currently available was FDA mandated to go through this process to prove safety and efficacy. This pipeline of new treatments and cures stops if trials cannot find participants. Clinical trials close and treatments and cures never make it to those who are ill.

After eight days at Emory University Hospital, Robinson says she feels better than ever and is more in-touch with her overall health. “The experience has been wonderful. I was actually very nervous going into it. I’ve never been away from my family for this long before. But I feel better, because you have to do a fast, can have no alcohol or caffeine, and I’ve actually gotten sleep. I feel refreshed, like a paid vacation,” said Robinson. The in-patient trial provides all meals, a room with a view, and the quiet needed for adequate rest. Something Robinson says she has not had since her first son was born eight years ago.

The Emory Hope Clinic needs more volunteer participants for this study and others. More information is available at www.hopeclinic.emory.edu and by calling 404-712-1371. The study is conducted by Emory’s Vaccine and Treatment Evaluation Unit (VTEU) funded by the U.S. National Institutes of Health (NIH).

RESOURCES
Read Brittany’s full story here
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Clinical Trials at Emory

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New Website Makes Searching For Emory Clinical Trials Easier

cthp-250x250We are thrilled to announce the launch of a new Emory clinical trials website! The new site – clinicaltrials.emory.edu – features easy-to-access information for nearly 1,000 active clinical trials at Emory that are currently seeking volunteers.

Potential clinical trial participants may easily search for trials related to a specific health condition or browse by topic areas such as cardiology, cancer, or neurosciences and view quick facts about each of the individual trials. While many clinical trials are seeking patients who have a particular disease, many others are seeking healthy volunteers.

“Emory’s ability to develop improved therapies through clinical research is a key component of our clinical mission and gives patients access to the most advanced treatments available,” says Jeffrey Lennox, MD, associate dean for clinical research in Emory University School of Medicine. “This new clinical trials website will allow more people within Emory and the broader community to learn about and participate in the wide range of available clinical trials.”

What Information Is Included On The New Website?

Each clinical trial listing includes information on its purpose, timing, key investigators, process, and eligibility criteria. For additional information, potential volunteers may click on a link to send a message the leader of each individual trial. Emory trials will continue to be listed in the National Institutes of Health (NIH) clinical trials database – clinicaltrials.gov– which provides more detailed information.

If you wish to learn more about clinical trials in general, the new website also includes frequently asked questions about volunteering, information on additional resources at Emory for potential participants, and NIH information about clinical trials.

The Value Of Clinical Trials

Medical advances and improvements to clinical care have been made possible the participation of volunteers in clinical trials. Some studies test new drugs or surgical procedures and devices, while others look for better ways to prevent diseases in people who have either never had a disease or are trying to prevent one from coming back. Other types of trials help find ways to improve the care and quality of life of people with long-term illnesses and diseases.

People choose to participate in clinical trials for a variety of reasons. Current patients may participate in order to receive care and potentially benefit from a new therapy. Healthy volunteers may participate in clinical trials to help current and future patients and to contribute to help researchers find better treatments.

For more information on clinical trials at Emory, please ask your Emory physician or call the Emory HealthConnection℠ at 404-778-7777.

 

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Understanding Clinical Trials – Part 2: What are the Benefits of Clinical Trials?

With any clinical trial, there are both benefits and risks associated; however, clinical trials are not just for sick people, unlike common perception. Both healthy people and people with certain diseases or conditions participate in clinical trials. While some participate to receive care or treatment only available through a clinical trial, others participate to help researchers find better treatments.

For researchers, physicians and health care professionals, clinical trials are extremely important because they allow us to make real-time differences in medicine. Treatment regimens, drugs and care-delivery protocols all exist today because of clinical studies conducted in the past. Clinical trials and research provide not only hope for our patients, but a possibility for better outcomes and medical advancements in the future.

As a leading academic medical center, Emory Healthcare is proud to offer more than 1,000 clinical trials to our patients. Some direct benefits patients receive by participating in clinical trials include:

  • Access to new treatments that are not yet available to the general public
  • Access to more effective treatments than the standard care therapies
  • Close oversight from medical experts at a leading health care facility in the Southeast
  • Helping others by contributing to medical research

The decision to participate in a clinical trial is completely voluntary; therefore, to help you and your loved ones decide whether or not to participate, it is important to understand any potential risks. The known risks and benefits are different depending on the clinical trial, so make sure you talk to members of the research team before making a decision.

In the video below, Emory researchers and doctors discuss the benefits of clinical trials.

Related Resources

Learn More About Clinical Trials at Emory Healthcare
Find a Clinical Trial at Emory

Is Insomnia Linked to High Blood Pressure?

insomnia clinical trialWith more than 1,000 clinical trials underway at Emory, today’s research is giving patients and families a better tomorrow. Read about one of our active nursing clinical trials below:

Hypertension, or high blood pressure, is a common but serious condition. According to the Centers for Disease Control and Prevention, about 1 in every 3 adults in the United States (about 70 million people) has high blood pressure.

Having high blood pressure means the pressure of blood in the blood vessels is higher than it should be, which can be a risk factor for heart disease and stroke, two of the leading causes of death for Americans.

While hypertension can be controlled through prescribed medications, lifestyle changes are equally as important. A healthy diet and exercise are known ways to lower blood pressure, but a clinical trial currently underway at the Nell Hodgson Woodruff School of Nursing at Emory University is investigating whether adequate sleep also helps reduce high blood pressure.

Insomnia – or trouble getting to sleep, staying asleep or early morning awakenings – is a very common sleep disorder associated with decreased quality of life, reduced work productivity and increased health care costs. In recent years, insomnia has also been associated with hypertension and cardiovascular disease.

In this particular study, funded by the American Heart Association, participants participate in an online sleep improvement program once a week for six weeks. The goal of the trial is to determine if the program is effective in lowering blood pressure and improving sleep, mood and cognition in people with insomnia and high blood pressure.

Do you have high blood pressure? Do you have trouble sleeping? Eligible participants will receive compensation for their time and effort. For more information, click to view the informational flyer for this trial>>

Related Resources

Find an Emory trial
Clinical Trials – FAQs
Understanding Clinical Trials – Part 1: What are Clinical Trials?
Emory School of Nursing

Clinical Trials: Leading the Way to Better Health Care

Emory Clinical TrialsAs the leading academic medical center in Georgia, Emory Healthcare is home to researchers and physicians who are pioneering or participating in thousands of clinical trials across the nation.

The discovery that comes from these research studies not only makes a different in the way health care is delivered, here and now, but impacts patient care for generations to come.

A recent Atlanta Business Chronicle article highlights twenty clinical trials across the state of Georgia that have the potential to make a big difference in health care. 15 out of the 20 trials identified are Emory-led or Emory-involved clinical trials.

Learn more about clinical trials at Emory Healthcare, or click to find an Emory clinical trial.

Also, make sure to read below to see the Atlanta Business Chronicle’s list of promising trials to keep and eye on.

  • LEUKEMIA CLINICAL TRIAL

    • Principal investigator: Dr. Anand Jillella, professor of Hematology and Medical Oncology at Emory University’s School of Medicine; associate director for Community Outreach at Emory University’s Winship Cancer Institute
    • Location: Winship Cancer Institute, Emory University
    • Summary: Currently, one-third of patients diagnosed with Acute Promyeloctic Leukemia don’t survive the third month of treatment. By simplifying patient care strategies, Jillella and his team claim they have found a way to decrease this mortality rate from 30 percent to less than 5 percent. Winship is heading a national clinical trial.
  • LUNG CANCER CLINICAL TRIAL

    • Principal investigator: Dr. Suresh Ramalingam, professor of hematology and medical oncology, Emory University School of Medicine; director of medical oncology and the lung cancer program at Winship Cancer Institute
    • Location: Winship Cancer Institute
    • Summary: This study compares three different approaches to treating patients with certain forms of lung cancer after receiving chemotherapy. The national study will include a total of 1,495 participants, more than 1,400 of which have already been enrolled.
  • GRAFT VS. HOST DISEASE CLINICAL TRIAL

    • Principal investigator: Dr. Muna Qayed, assistant professor of pediatric bone marrow transplantation at Emory School of Medicine; physician, pediatric hematology and oncology, Children’s Healthcare of Atlanta; Jacques Galipeau, study sponsor, director of the Emory Personalized Immunotherapy Center, which manufactures cells using a unique processing technique
    • Location: Emory University School of Medicine, Children’s Healthcare of Atlanta, and Emory Personalized Immunotherapy Center (EPIC)
    • Summary: Qayed’s team is in Phase I of a trial that will test personalized cell therapy for the treatment of graft-versus-host disease (GVHD), a life threatening complication that affects anywhere from 30 to 70 percent of patients who undergo bone marrow transplantation. For patients who don’t respond to the first-line therapy (steroids) the disease can be fatal up to half the time. The study involves removing the participant’s own stem cells, manufacturing more of those cells and then infusing them back into participants.
  • BREAST CANCER CLINICAL TRIAL

    • Principal investigator: Dr. Wendy Painter, CEO of Que Oncology
    • Location: Que Oncology, a biotechnology company formed by Emory University and Brisbane, Australia-based UniQuest, the University of Queensland’s commercialization company, in partnership with Morehouse School of Medicine
    • Summary: This study aims to treat hot flashes in women receiving anti-estrogen therapy for breast cancer with Q-122, Que Oncology’s lead compound. Nearly 60 percent of participants experienced a reduction in hot flashes during Phase I of the study, which wrapped in November 2014.
  • CROHN’S DISEASE CLINICAL TRIAL

    • Principal investigator: Dr. Subra Kugathasan, Marcus professor of pediatric gastroenterology at Emory School of Medicine; physician, Children’s Healthcare of Atlanta
    • Location: Emory University School of Medicine, Children’s Healthcare of Atlanta and Emory Personalized Immunotherapy Center (EPIC)
    • Summary: Physician-researchers at Emory University and Children’s Healthcare of Atlanta are using “personalized” cellular therapy to treat older adolescents and adults suffering from Crohn’s disease by harvesting participants’ own marrow cells and manufacturing personalized ones to target the disease’s inflammatory mechanisms, potentially reducing intestinal flare-ups and minimizing long-term damage.
  • EBOLA CLINICAL TRIAL

    • Principal investigator: Dr. Anne Winkler and Dr. Colleen Kraft, assistant professors in pathology and laboratory medicine at Emory University School of Medicine
    • Location: Emory University Hospital
    • Summary: Investigators are collecting plasma from U.S. Ebola survivors to see if it could possibly prove effective when used in conjunction with standard treatment methods. Following the donor apheresis procedure which removes the plasma component from the blood and returns red blood cells to the donor, the plasma is treated with a device called the Intercept Blood System to remove any potential pathogens. The plasma is stored with the aim of using its antibodies to neutralize the active virus in the recipient’s blood.
  • PANCREATIC CANCER CLINICAL TRIAL

    • Principal investigator: Dr. David Kooby, professor of surgery, Emory University School of Medicine; director of surgical oncology, Emory Saint Joseph’s Hospital
    • Location: Winship Cancer Institute
    • Summary: One of the challenges in pancreatic cancer surgery is ensuring the removal of the entire cancer, as cancer cells can extend beyond the actual mass into the nearby normal-appearing pancreas. This study uses a novel application of a well-studied dye called indocyanine green coupled with a pen-shaped detection device (SpectroPen). The dye leaks out of the small vessels around the tumor cells, and the pen can be used to measure this leaking dye to detect cancer in the surrounding pancreas. This can help surgeons achieve complete cancer removal in more patients and it can help pathologists assess the tumor tissue more thoroughly to improve staging and better guide treatment.
  • BLINDNESS CLINICAL TRIAL

    • Principal investigator: Dr. Stephen Yeh, associate professor of ophthalmology and director of the section of uveitis and vasculitis at Emory Eye Center is running the uveitis study; Dr. Andrew Hendrick, assistant professor of ophthalmology at Emory Eye Center is running the retinal vein occlusion study.
    • Location: Clearside Biomedical has eight trial sites across the U.S., including Emory University
    • Summary: Drug development company Clearside Biomedical is conducting a trial on a micro-injector platform technology that allows surgeons to deliver medicine to treat the leading causes of blindness directly into the retina, improving the drug’s effectiveness while reducing side effects that can occur when the drug enters other parts of the eye. Clearside is currently conducting a trial on of uveitis, inflammation associated with the back of the eye. It’s also running a Phase II study in retinal vein occlusion.
  • EBOLA VACCINES CLINICAL TRIAL

    • Principal investigator: N/A
    • Location: GeoVax in Smyrna, Ga.
    • Summary: This tiny biotech company, of which Emory University is the single largest shareholder, is developing a second-generation preventive vaccine against the three strains of the Ebola virus. CEO Bob McNally said the goal is to have the vaccine ready for Phase I testing by next year in preparation for the next outbreak of the disease.
  • ALZHEIMER’S DISEASE CLINICAL TRIAL

    • Principal investigator: Dr. Ihab Hajjar, associate professor of medicine, Emory University School of Medicine
    • Location: Emory University
    • Summary: Hajjar’s team is conducting a one-year study (Calibrex) of the relationship between high blood pressure and Alzheimer’s disease. They will try to determine whether drug treatment for high blood pressure can affect those factors associated with Alzheimer’s disease. Eligible participants are older than 60, hypertensive, and have mild cognitive impairment.
  • HIGH BLOOD PRESSURE CLINICAL TRIAL

    • Principal investigator: Dr. Chandan Devireddy, associate professor of medicine, Emory University School of Medicine
    • Location: Emory University
    • Summary: In August 2013, Emory was the first in the world to implant a MobiusHD device, a catheter-delivered implant that can help lower high blood pressure without the use of medication. It is one of nine centers in the United States conducting a study to evaluate the device and how it compares to standard treatments for people with treatment-resistant high blood pressure.
  • HEART FAILURE CLINICAL TRIAL

    • National co-principal investigator: Dr. Vinod Thourani, professor of surgery, Division of Cardiothoracic Surgery, Emory School of Medicine; chief of cardiothoracic surgery, Emory Hospital Midtown, co-director, Structural Heart and Valve Center
    • Emory investigator: Dr. Vasilis Babaliaros, associate professor of medicine, Emory School of Medicine, co-director, Structural Heart and Valve Center.
    • Location: Emory University
    • Summary: Emory is now enrolling qualified patients for its Partner II Sapien 3 trial for aortic valve replacements, a groundbreaking nonsurgical treatment for patients with failing aortic valves who are considered intermediate risk for surgical therapy. Emory was the first center in the Southeast to place a Sapien valve in a patient without opening the chest and the first in the U.S. to implant the newest generation Sapien 3 valve. It is one of the largest enrolling centers for the national clinical trial to evaluate this latest generation of transcatheter aortic valves.
  • CANCER PAIN CLINICAL TRIAL

    • Principal investigators: Dr. Mark Rapaport, Reunette W. Harris professor and chair of the Department of Psychiatry and Behavioral Sciences at Emory University School of Medicine, and chief of psychiatric services, Emory Healthcare; and lead investigator, Dr. Mylin Torres, associate professor in Emory University’s Department of Radiation Oncology
    • Location: The Emory Brain Health Center, Department of Psychiatry and Behavioral Sciences
    • Summary: Previous research conducted by Rapaport has shown that massage therapy can boost the immune system and decrease anxiety for people who do not have cancer. In this study, the researchers are investigating the effects of massage on the debilitating fatigue post-surgery cancer patients experience as a result of chemotherapy, chemo-prevention and/or radiation.
  • DEPRESSION CLINICAL TRIAL

    • Principal investigator: Dr. Helen Mayberg, professor of psychiatry and neurology at Emory University School of Medicine, and Dorothy C. Fuqua Chair in Psychiatric Neuroimaging and Therapeutics
    • Location: Emory University School of Medicine
    • Summary: Mayberg leads a team of researchers studying the results of implanting electrodes into a pinpointed region of the brain believed to be responsible for regulating depression in some people. The electrodes send electrical impulses to interrupt faulty brain circuits in that portion of the brain. The study targets patients whose depression has resisted treatment by any other means. Various phases of clinical trials have been ongoing since 2003. Subsequent trials on patients with unipolar and bipolar depression have shown promising results.
  • ALZHEIMER’S CLINICAL TRIAL

    • Principal investigator: Whitney Wharton, assistant professor of neurology, Emory University School of Medicine
    • Location: Emory University
    • Summary: Wharton’s team is studying the effects of blood flow on factors that contribute to Alzheimer’s disease. Participants come to the university once annually for cognitive assessments, blood pressure monitoring, vascular ultrasounds and lumbar puncture.

Related Resources

Find an Emory Trial
Clinical Trials – FAQs
Understanding Clinical Trials – Part 1: What are Clinical Trials?

Understanding Clinical Trials – Part 1: What are Clinical Trials?

What is a Clinical Trial

WATCH Winship at Emory patient and clinical trial participant, Holly Johnston, discuss her decision to enroll in a cancer clinical trial.

Clinical trials are an essential part of moving research forward and most medical advances have been made possible because of volunteer participation in clinical trials.

At Emory Healthcare, clinical trials are at the core of our mission where discovery and research fuel exceptional patient-and-family-centered care. But for many people, clinical studies seem complicated and intimidating. To answer some popular questions about clinical trials and clear up common misunderstandings, we are launching a six-part series on understanding clinical trials and why they are an important part of patient care.

What are clinical trials?

A clinical trial is a form of research that uses human volunteers (called participants) to answer specific questions that help doctors understand new ways to prevent, diagnose and treat diseases.

Existing treatments today may not be effective for everyone, so clinical trials help determine if new drugs, diagnostics or procedures are safe and effective before they are made widely available. There are different types of clinical trials, but all start with a question. An example question would be “does the dose of this drug impact its effectiveness?” A well-designed clinical trial is set up to provide answers to the original question.

What happens during a clinical trial?

Every clinical trial is led by a principal investigator, who is usually a medical doctor, and they typically have a research team including doctors, nurses, social workers and other members of the care team. New treatment therapies are usually tested in three separate phases before regulatory agencies consider them safe and effective.

During a clinical trial, data is collected to help inform the study outcome, which can be positive or negative. Either way, a clinical study is successful if the answer to the initial question is clear and has a solid foundation of scientific data to support it. Even if the outcome is different than the principal investigator’s hypothesis, the end result informs which direction the research team should take next.

Clinical Trials at Emory

There are more than 1,000 clinical trials underway at Emory Healthcare and the outcomes are not only making a difference in people’s lives here and now, but for generations to come.

As we continue our blog series on understanding clinical trials, we want to know what questions you have about clinical trials and clinical research. Leave your questions in the comments field below and your question may just get answered by an Emory researcher!

Also, click to see a list of frequently asked questions about clinical trials.

Related Resources

Stroke Rehabilitation Clinical Trial a Top International Trial

Rehab Clinical TrialAt Emory, clinical trials are at the core of our mission and we are proud to offer them to our patients. Groundbreaking scientific advances and medical treatments available today have been made possible because of volunteer participation in clinical trials and research.

In fact, one of the thousands of clinical trials conducted at Emory was just identified as one of the 15 top international clinical trials ever published for physical therapy and rehabilitation.

The EXCITE (Extremity Constraint-Induced Therapy Evaluation) trial, led by Emory University’s Steven Wolf, PhD, PT, professor of rehabilitation medicine at Emory University, was created to teach stroke patients to use their stroke-affected arm rather than their “good” arm. Conducted almost a decade ago, the clinical trial was found to have a significant impact in stroke rehabilitation, which set the stage for many future trials.

Each year, more than 795,000 people in the United States suffer from a stroke and many stroke survivors experience partial paralysis on one side of the body. The EXCITE trial enrolled 222 patients who had suffered a stroke, predominantly an ischemic stroke, within the previous three to nine months.

During the trial, participant’s less-impaired hand was restrained and/or immobilized by placing a mitt around the “good” arm in an effort to encourage use of the affected extremity. Participants engaged in daily repetitive tasks and behavioral therapy sessions, which included training in tasks such as opening a lock, turning a doorknob or pouring a drink. Only use of the affected arm was allowed during exercise.

“Often, stroke rehabilitation focuses on teaching patients how to better rely on their stronger limbs, even if they retain some use in the impaired limbs, creating a learned disuse,” says Wolf. “This trial was just the opposite and focused on the impaired limb, which proved to be a valuable form of rehabilitation. We are so pleased and honored that this clinical trial has been found to be a top 15 trial amongst an international jury of experts.”

Wolf, and other Emory University researchers partaking in the national trial, studied participants to determine if the intervention improved motor function, as compared to no therapy at all. Patients were evaluated using the Wolf Motor Function Test (named after Wolf), which is a measure of laboratory time, strength-based ability and quality of movement.

Research investigators found that over the course of a year from the beginning of therapy, the group undergoing constraint-induced therapy showed greater improvements than the control group in regaining function.

“Results showed that constraint-induced movement therapy produced statistically significant and clinically relevant improvements in arm motor function that persisted for at least one year at follow-up,” says Wolf. “This trial was the first large multi-center, randomized controlled trial in stroke rehabilitation that lay the ground work for many other trials to follow.”

The EXCITE trial was funded by the National Institutes of Health from 2000-2005 and the results were published in JAMA in 2006. For the past 15 years, PEDro, a database located and supported within the George Institute for Global Health in Australia, has reviewed clinical trials, guidelines and reviews of work related to rehabilitation and physical therapy. During that time period, around 28,000 trials and manuscripts dating back as far as 1929 were reviewed. The free database is used by thousands of physiotherapists and others interested in rehabilitation from more than 200 countries. Out of the 15 trials highlighted by PEDro, only two were clinical trials based in the U.S.

Click to learn more about clinical trials at Emory, or call 404-778-7777.

Related Resources

Emory’s Stroke Rehabilitation Clinical Trial Chosen as Top International Trial

Rehab Clinical TrialAt Emory, clinical trials are at the core of our mission and we are proud to offer them to our patients. Groundbreaking scientific advances and medical treatments available today have been made possible because of volunteer participation in clinical trials and research.

In fact, one of the thousands of clinical trials conducted at Emory was just identified as one of the 15 top international clinical trials ever published for physical therapy and rehabilitation.

The EXCITE (Extremity Constraint-Induced Therapy Evaluation) trial, led by Emory University’s Steven Wolf, PhD, PT, professor of rehabilitation medicine at Emory University, was created to teach stroke patients to use their stroke-affected arm rather than their “good” arm. Conducted almost a decade ago, the clinical trial was found to have a significant impact in stroke rehabilitation, which set the stage for many future trials.

Each year, more than 795,000 people in the United States suffer from a stroke and many stroke survivors experience partial paralysis on one side of the body. The EXCITE trial enrolled 222 patients who had suffered a stroke, predominantly an ischemic stroke, within the previous three to nine months.

During the trial, participant’s less-impaired hand was restrained and/or immobilized by placing a mitt around the “good” arm in an effort to encourage use of the affected extremity. Participants engaged in daily repetitive tasks and behavioral therapy sessions, which included training in tasks such as opening a lock, turning a doorknob or pouring a drink. Only use of the affected arm was allowed during exercise.

“Often, stroke rehabilitation focuses on teaching patients how to better rely on their stronger limbs, even if they retain some use in the impaired limbs, creating a learned disuse,” says Wolf. “This trial was just the opposite and focused on the impaired limb, which proved to be a valuable form of rehabilitation. We are so pleased and honored that this clinical trial has been found to be a top 15 trial amongst an international jury of experts.”

Wolf, and other Emory University researchers partaking in the national trial, studied participants to determine if the intervention improved motor function, as compared to no therapy at all. Patients were evaluated using the Wolf Motor Function Test (named after Wolf), which is a measure of laboratory time, strength-based ability and quality of movement.

Research investigators found that over the course of a year from the beginning of therapy, the group undergoing constraint-induced therapy showed greater improvements than the control group in regaining function.

“Results showed that constraint-induced movement therapy produced statistically significant and clinically relevant improvements in arm motor function that persisted for at least one year at follow-up,” says Wolf. “This trial was the first large multi-center, randomized controlled trial in stroke rehabilitation that lay the ground work for many other trials to follow.”

The EXCITE trial was funded by the National Institutes of Health from 2000-2005 and the results were published in JAMA in 2006. For the past 15 years, PEDro, a database located and supported within the George Institute for Global Health in Australia, has reviewed clinical trials, guidelines and reviews of work related to rehabilitation and physical therapy. During that time period, around 28,000 trials and manuscripts dating back as far as 1929 were reviewed. The free database is used by thousands of physiotherapists and others interested in rehabilitation from more than 200 countries. Out of the 15 trials highlighted by PEDro, only two were clinical trials based in the U.S.

Click to learn more about clinical trials at Emory, or call 404-778-7777.

Related Resources

Clinical Trials – FAQs

Clinical Trials at EmoryAt Emory Healthcare, we are proud to sponsor clinical trials and offer the opportunity for our patients to participate in them. Currently there are more than 1,000 clinical trials offered throughout our health care system. As one of the nation’s leading academic medical systems, our involvement in clinical trials sets us apart from other health care organizations. Access to advanced resources and technology allows our care team to provide patients with the most effective and progressive treatments. It’s only once these treatments are approved that they’re made available elsewhere.

Medical advances and improvements to patient care have been made possible by clinical trials and the participation of volunteers. Below are answers to frequently asked questions you may have about clinical trials.

Q. What is a clinical trial?

A. A clinical trial is a form of research that uses human volunteers (called participants) to help answer specific questions about new ways to prevent, diagnose and treat diseases. Clinical trials are extremely important because they allow researchers to work with patients suffering from the exact condition they are trying to treat.

Q. What types of clinical trials are available at Emory?

A. There are several forms of clinical trials. Some trials test new drugs, procedures or other treatments, and others look for better ways to prevent diseases in people who have either never had a disease or are trying to keep one from coming back. Some trials are used to develop better ways to diagnose a particular disease or condition while other trials help find ways to improve the care and quality of life of people with long-term illnesses.

Q. What do the different phases of trials mean?

A. Clinical trials take place in “phases,” and each phase helps researchers answer specific questions.

Phase I Clinical Trials: These trials are used to test brand new drugs, devices or procedures to find out how safe they are and identify possible side effects. They usually involve 20 to 80 people.

Phase II Clinical Trials: These trials are used to further evaluate the effectiveness and safety of a drug, device or procedure. The researchers keep track of any medical benefits, as well as side effects. They usually involve 100 to 300 people.

Phase III Clinical Trials: These trials compare a new treatment or procedure with a standard old treatment or procedure to figure out which works best. Evaluation of side effects and effectiveness continues. They usually involve 1,000 to 8,000 people.

Phase IV Clinical Trials: Once a drug or procedure is approved by the U.S. Food and Drug Administration (FDA) and made available to the public, researchers continue to study its safety to figure out the best use of the new treatment.

Q. Who can participate in clinical trials?

A. Both people in good health and people with certain diseases or conditions participate in clinical trials. People participate in trials to help researchers find better treatments, or to receive care or treatment only available as part of a clinical trial.

Q. How does clinical research make a difference?

A. Clinical research helps us learn about the safety and effectiveness of all drugs, procedures and other
treatments. Medical advances like new drugs and surgical procedures are made possible because of clinical trials and the voluntary participation of individuals.

At Emory, we’re conducting clinical trials and research to make a difference in people’s lives, here and now and for generations to come. While there are many benefits to participating in clinical trials, there can also be risks, which is why it is important to speak with a physician before deciding to participate. For more information on clinical trials at Emory, please view a complete list of our Frequently Asked Questions. If you have additional questions, visit our clinical trials website or call 404-778-7777.

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