Posts Tagged ‘clinical trial’

Breakthrough clinical study exposes crucial role parents play in behavior management for children with autism

parent-childHighlighted in an April issue of the Journal of the American Medical Association, a clinical trial involving Emory University and the Marcus Autism Center provided insight into the effect parent training has on managing disruptive behavior with young children with autism spectrum disorder (ASD) and serious behavioral problems.

ASD is a chronic condition beginning in early childhood and is mostly characterized by impaired social communication and repetitive behavior. Commonly, severe behavioral problems accompany ASD in young children including tantrums, aggression, self-injury and severe noncompliance in response to routine environmental demands. For parents of children with ASD, these disruptive behaviors can be overwhelming and produce uncertainty on how to handle these problems. While there are approved medications for these disruptive behavioral problems, many parents are often reluctant to use medication.

In the multi-location study, 180 children (age 3 to 7 years) with ASD and serious behavioral problems were randomly assigned to either 24 weeks of parent training or 24 weeks of parent education. The study aimed to measure the effect of parent training in managing disruptive behaviors versus basic parent education. The following provides more detail on the difference between the two groups:

  • Parent training provided parents with specific/ practical skills and techniques for how to manage serious behavioral problems.
  • Parent education offered useful information on autism – but did not provide guidance on how to manage serious behavioral problems.

Study results were documented by both parents of the participating children, as well a clinician who was blind to treatment assignment:

  • Parent ratings: after 24 weeks of treatment, children in the parent-training group showed a 48 percent improvement on disruptive behavior compared to a 32 percent decline for parent education.
  • Clinician ratings: at week 24, 70 percent of children in the parent-training group showed a positive response, compared to 40 percent for parent education.

“This is the largest randomized trial of any behavioral intervention in children with autism spectrum disorder, and it shows that parent training works,” notes Lawrence Scahill, MSN, PhD, professor of pediatrics at Marcus and Emory School of Medicine, who directed the study.

Overall study results: while children in both groups improved, parent training was more effective in reducing disruptive and aggressive behavior than parent education. In fact, the benefits of parent training continued for up to six months after the clinical trial, demonstrating the benefits of parent training last over time.

Despite the increased methods for recognizing ASD in young children, rigorous testing and the distribution of evidenced-based treatments have lagged. Using the results of this study, researchers and physicians are able to show the impact of parent training and disseminate learned practices to a wider population.

To find an autism-related clinical trial at Emory, click the “Search for a clinical trial at Emory” link and type in the terms “Autism” and “Emory” into the search field.

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?

New Study Finds Possible Link Between Low Vitamin D Levels and Parkinson’s Disease

Past research has indicated that their may be a link between low vitamin D levels and Parkinson’s Disease, but a cause-and-effect relationship between the two has never been established. However, a recent study discussed in a July 2010 Archives of Neurology editorial (written by assistance professor of neurology at Emory University School of Medicine, Marian Evatt, MD) demonstrates a significant need for additional research on whether vitamin D supplements can help prevent Parkinson’s.

neurons

The study is the first to demonstrate that low vitamin D levels are a telling factor in predicting a person’s likelihood for developing Parkinson’s Disease. The study tested vitamin D levels in blood samples taken from over 3000 people from 1978-90 and followed the participants to observe whether Parkinson’s was developed later in life. A fairly telling result was witnessed – participants with the lowest vitamin D levels were 3x more likely to develop Parkinson’s when compared to individuals in the group with the highest vitamin D levels.

Dr. Evatt believes that vitamin D may help prevent the gradual degradation of neurons displayed in people with Parkinson’s. Neurons that are typically lost over time in individuals suffering from Parkinson’s are responsible for production of dopamine to help control movement, which is why stiffness, tremor, and general slow movement are common symptoms of the disease. Recent research conducted on animals, however, suggests that vitamin D may be able to help protect these neurons.

Dr. Evatt and her colleagues are currently holding a pilot clinical trial to explore the effects of vitamin D supplements on Parkinson’s patients with low vitamin D levels. She is also involved in research and epidemiological studies of the vitamin’s effects on the disease. In her editorial, Dr. Evatt makes a recommendation for raising the target/recommended vitamin D levels due to its obvious benefits for bone health and potential benefits to the nervous system.

If you’re interested in making sure your vitamin D levels are where they should be, fish such as salmon and tuna, milk, mushrooms and exposure to sunlight are good sources of vitamin D.