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Trial record 54 of 146 for:    epilepsy AND Bethesda

Temperature Response to a Head-Neck Cooling System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00025987
Recruitment Status : Completed
First Posted : November 5, 2001
Last Update Posted : March 4, 2008
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Healthy Device: Head and Neck Cooling System Device: Thermometer Pill Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Primary Purpose: Treatment
Official Title: Thermal Responses In Normal Volunteers To Head-Neck Cooling
Study Start Date : November 2001
Study Completion Date : April 2003

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00025987

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United States, Maryland
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

Layout table for additonal information Identifier: NCT00025987     History of Changes
Other Study ID Numbers: 020025
First Posted: November 5, 2001    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: April 2003
Keywords provided by National Institutes of Health Clinical Center (CC):
Cooling of the Head and Neck
Healthy Volunteer