Temperature Response to a Head-Neck Cooling System

March 3, 2008 updated by: National Institute of Neurological Disorders and Stroke (NINDS)

Thermal Responses In Normal Volunteers To Head-Neck Cooling

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Study Completion

April 1, 2003

Study Registration Dates

First Submitted

November 2, 2001

First Submitted That Met QC Criteria

November 2, 2001

First Posted (Estimate)

November 5, 2001

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

April 1, 2003

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 020025
  • 02-N-0025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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