Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00067210
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2003-08-12
Brief Title:
Reducing Seizure Frequency Using Cooling of the Head and Neck
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Cooling of the Head and Neck to Reduce Seizure Frequency A Pilot Study
Status:
COMPLETED
Status Verified Date:
2008-06-13
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Previous experimental as well as clinical reports have clearly shown that cooling of the brain does have inhibitory effects on epileptiform discharges and seizures We hypothesize that mild cooling of the brain has anti-epileptic effects in epileptic patients who either have no identifiable seizure foci who have multiple foci or who have frequent localization-related seizures that are refractory to antiepileptic drugs We have studied the feasibility and safety of a head-neck cooling device in 10 adult normal volunteers and found that the head-neck cooling was feasible and safe without significant complaints or problems voiced by the subjects Overall a slight reduction of core temperature was shown Since cooling on a twice-a-week basis was well tolerated by normal volunteers we would like to extend our study to patients with epilepsy to learn the optimal duration and frequency of head-neck cooling in terms of reducing seizure frequency This will be a pilot study as directed by PIRC and the IRB in which we will evaluate 60 minutes of cooling performed once a week for 4 weeks in 5 epileptic patients We will then report the results to PIRC and the IRB before we proceed with further study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-N-0272 | None | None | None |