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NCT00067210 · ClinicalTrials.gov registry record · Phase 2
Reducing Seizure Frequency Using Cooling of the Head and Neck
A Phase 2 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT00067210 is a Phase 2 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 5 participants.
The verdict
NCT00067210, a Phase 2 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
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.
Interventions
- DEVICE Head and Neck Cooling System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2003-08-11 |
| Est. Completion | 2007-05-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00067210
The ClinicalTrials.gov registry entry for NCT00067210 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Head and Neck Cooling System is the first listed.
NCT00067210 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00067210 about?
NCT00067210 is a clinical study titled "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. Research...
What is the current status of trial NCT00067210?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2003-08-11. Estimated completion is 2007-05-22.
What interventions are being tested in trial NCT00067210?
The interventions under investigation include: Head and Neck Cooling System (DEVICE).
Who is sponsoring clinical trial NCT00067210?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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