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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: Completed Phase 2 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00067210 record still lists
NCT00067210 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Head and Neck Cooling System is the first listed.
NCT00067210 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00067210's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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