- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00067210
Reducing Seizure Frequency Using Cooling of the Head and Neck
Cooling of the Head and Neck to Reduce Seizure Frequency: A Pilot Study
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 Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
A minimum of one documented seizure of any type per a 1-week period.
21 years or older, and able to cooperate with the cooling procedures.
On a stable antiepileptic drug (AED) regimen, as determined by history and by AED plasma levels as measured in the CC OPD.
The ability to maintain a daily seizure calendar, either independently or with help from a family member.
No history of intestinal problems or history of intestinal surgery.
Must be able to swallow medication in capsule form.
EXCLUSION CRITERIA:
Female patients who are pregnant.
Those patients under 21 years of age.
Those patients who may have difficulty swallowing a large capsule, or describing their feelings and experiences related to the cooling sessions.
Those patients with a history of intestinal problems or intestinal surgery
Those patients with progressive neurological disorders
Those sensitive to coldness
History of severe 'ice-cream' headache
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Identify optimal cooling parameters,namely duration and frequency of cooling for reducing seizure frequency.
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 030272
- 03-N-0272
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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