Low Glycemic Index Treatment for Seizures in AS
Dear Families Interested in Angelman Research:
We would like to let you know about a new study for Angelman syndrome (AS). “Low Glycemic Index Treatment for Seizures in Angelman Syndrome” is a clinical study examining the effects of the Low Glycemic Index Treatment (LGIT) on seizures in people with AS. One of the most effective treatments for “intractable” epilepsy (seizures that cannot be controlled with standard medications) is the Ketogenic Diet. The Ketogenic Diet is a high-fat diet that carefully controls the amount of carbohydrates (sugars and starches) and proteins that a person with seizures eats. This diet has helped many patients with epilepsy reduce the number of seizures they have. Although it helps to reduce seizures, many people find it difficult to stay on the ketogenic diet. The LGIT allows a little more of certain kinds of carbohydrates and proteins than the Ketogenic Diet does. Doctors at Massachusetts General Hospital for Children (MGHfC) Dietary Therapy and Epilepsy Clinic have developed this new diet and have already used it in over 100 children.
To be eligible, a participant must have a laboratory or clear clinical diagnosis of AS with seizures occurring at least once per month, and be under 18 years of age. All study participants will be asked to fill out a seizure diary for one month, and record everything they eat for 3 days. They will then come to our clinic at MGHfC in Boston where an EEG will be performed and 3 neuropsychological questionnaires will be administered to establish a baseline. They will then meet with our clinic dietitian to formulate meal plans and receive education about the diet, which they will stay on for 4 months. Routine blood work will be obtained at this time. Another seizure diary will be given to fill out over the course of the 4-month study. At one month, blood will again be drawn and they will speak with our dietitian either in person or by phone if living outside the Boston area. At 4 months, there will be a second visit to repeat the EEG and neuropsychological questionnaires to assess change from baseline, and seizure diaries will be reviewed. This will be the end of the study, but if they feel the diet is beneficial, we will continue to follow them as long as they choose to stay on the diet. Participants will need to travel to the study site for both visits.
Travel costs are the responsibility of the family. The EEGs and questionnaires are of no cost to families, and clinic visits and blood draws are billed to insurance as they are standard of care. A small stipend, $25 per visit, will be given to study participants to help defer costs of parking and lunch while at MGHfC.
The risks associated with taking part in this study include: 1) possible loss of confidentiality (confidentiality will be protected to the full extent required by law); 2) mild discomfort with cleaning of the skin and removal of adhesive electrodes and with the 3 blood draws, and 3) other events that cannot be anticipated or predicted. Be sure to discuss all potential risks of the study procedures with the study doctor, your child’s physician, and your family before you agree to participate.
The direct benefits from this study may include better seizure control, better cognitive and behavioral functioning, and improved EEG results. The scientific community will also benefit through increased understanding of AS which may lead to better care of individuals with AS.
Taking part in this study is voluntary. If you choose to let your child take part, you may choose to leave the study at any time. Your decision will not result in any penalty or loss of benefits to which your child is entitled.
If you would like more information regarding this study, please contact:
Ronald Thibert DO, MSPH or
Elizabeth Thiele MD, PhD
Pediatric Epilepsy Program
Massachusetts General Hospital
175 Cambridge Street, Suite #340
Boston, MA 02114
Telephone: 617-726-6540
rthibert@partners.org