Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025987
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-11-02
Brief Title:
Temperature Response to a Head-Neck Cooling System
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Thermal Responses In Normal Volunteers To Head-Neck Cooling
Status:
COMPLETED
Status Verified Date:
2003-04
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:
This study will evaluate the effectiveness of a specially designed head-neck cooling system for way lowering the bodys central or core temperature and cooling the brain Brain cooling has an effect on stopping seizure discharges in the brain as well as the seizures themselves If this system works to cool the brain a similar study may be tried in patients with epilepsy
Normal volunteers 21 years of age and older who have no medical or neurological condition and do not use any medications may be eligible for this study Candidates will be screened with an interview Women will have a pregnancy test Those enrolled will be hospitalized twice for overnight stays with the admissions 2 to 3 days apart
Participants will have a medical history physical and neurological examinations electroencephalogram EEG and electrocardiogram EKG Then electrodes will be attached to their scalp forearm and calf to measure temperatures in those locations Intestinal core temperature will be measured with a temperature-sensing pill which will be swallowed earlier and a hand-held infrared thermometer will be used to measure temperatures from the ear canal face head arms legs and abdomen Electrodes on the scalp will also measure changes in blood volume in the brain for a study of brain blood flow Subjects will be seated in a comfortable chair and fitted with the cooling system a portable unit with a circulating coolant Cooling will last 30 minutes for the first session and 60 minutes for the second Participants will be monitored for at least 30 minutes after each session to track temperature changes and have a post-cooling EEG recording
Normal volunteers 21 years of age and older who have no medical or neurological condition and do not use any medications may be eligible for this study Candidates will be screened with an interview Women will have a pregnancy test Those enrolled will be hospitalized twice for overnight stays with the admissions 2 to 3 days apart
Participants will have a medical history physical and neurological examinations electroencephalogram EEG and electrocardiogram EKG Then electrodes will be attached to their scalp forearm and calf to measure temperatures in those locations Intestinal core temperature will be measured with a temperature-sensing pill which will be swallowed earlier and a hand-held infrared thermometer will be used to measure temperatures from the ear canal face head arms legs and abdomen Electrodes on the scalp will also measure changes in blood volume in the brain for a study of brain blood flow Subjects will be seated in a comfortable chair and fitted with the cooling system a portable unit with a circulating coolant Cooling will last 30 minutes for the first session and 60 minutes for the second Participants will be monitored for at least 30 minutes after each session to track temperature changes and have a post-cooling EEG recording
Detailed Description:
The aim of this protocol is to study thermal responses in normal volunteers using a special cooling system designed to cool the head and neck Temperature will be monitored at various locations including the scalp face mouth ears tympanic arms legs and rectum Previous studies indicate that cooling of the brain can be achieved with the head-neck cooling method We hope to derive cooling parameters that will be used in a future study involving patients with epilepsy
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 |
|---|---|---|---|
| 02-N-0025 | None | None | None |