Temperature Response to a Head-Neck Cooling System

Completed · Phase 1

Conditions studied: Healthy

In brief

This study will evaluate the effectiveness of a specially designed head-neck cooling system for way lowering the body's 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.

Key facts

Study ID

NCT00025987

Run by

National Institute of Neurological Disorders and Stroke (NINDS)

People needed

10

Starts

2001-11-01

Expected to finish

2003-04-01

Last updated by the study team

2008-03-04

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 21 years and older
• No neurological or medical condition
• No use medication of any kind, including prescription, over-the-counter or herbal medicines.
• No history of any kind of gastrointestinal tract disorders

You may not qualify if…

• Women who are pregnant (screened with urine pregnancy test)
• Those with progressive neurological disorders
• Those sensitive to coldness
• Those taking medication
• Those who smoke
• Those whose heart rate less than 50 or more than 100
• Those who are less than 80 pounds or excessively overweight
• Those who have a history of gastrointestinal disorders (i.e. diverticulitis and other inflammatory bowel diseases)
• Those who have difficulty swallowing or whose gag reflex is impaired

Where it is running

• National Institute of Neurological Disorders and Stroke (NINDS) — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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