Reducing Seizure Frequency Using Cooling of the Head and Neck
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|ClinicalTrials.gov Identifier: NCT00067210|
Recruitment Status : Completed
First Posted : August 13, 2003
Last Update Posted : July 2, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy Seizures||Device: Head and Neck Cooling System||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||5 participants|
|Official Title:||Cooling of the Head and Neck to Reduce Seizure Frequency: A Pilot Study|
|Study Start Date :||August 11, 2003|
|Study Completion Date :||May 22, 2007|
- Identify optimal cooling parameters,namely duration and frequency of cooling for reducing seizure frequency.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067210
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|