Reducing Seizure Frequency Using Cooling of the Head and Neck
Doctors use cooling of the brain to help stop seizures. This procedure is usually accomplished through surgery. Cooling of the face and scalp may also cool the brain, avoiding the need for surgery.
The purpose of this study is to assess a head-neck cooling device that the patient can wear. Researchers will determine whether the device can change the frequency of seizures in people with epilepsy.
Study participants must be 21 years of age or older and must experience seizures that occur once a week on a regular basis. Participants will be asked to keep a detailed seizure diary for a 12-week period before the date of the first cooling session. For each of the four cooling sessions, participants will be admitted to the hospital overnight. They will undergo a physical and neurological exam and an EEG (electroencephalogram). They will also swallow a temperature-sensor pill. Participants will have one 60-minute cooling session once a week for 4 weeks. Investigators will paste temperature-sensing electrodes on the scalp, forearm, abdomen, and leg. Participants will then be fitted with the cooling unit and the session will begin.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Cooling of the Head and Neck to Reduce Seizure Frequency: A Pilot Study|
- Identify optimal cooling parameters,namely duration and frequency of cooling for reducing seizure frequency.
|Study Start Date:||August 11, 2003|
|Estimated Study Completion Date:||May 22, 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067210
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|