NCT00025987

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Nov 2001

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2001

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
Last Updated

March 4, 2008

Status Verified

April 1, 2003

First QC Date

November 2, 2001

Last Update Submit

March 3, 2008

Conditions

Healthy

Keywords

BrainTemperatureLowerTympanicRectalCooling of the Head and NeckControlEpilepsyHealthy VolunteerHV

Interventions

Head and Neck Cooling SystemDEVICE
Thermometer PillDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Amoateng-Adjepong Y, Del Mundo J, Manthous CA. Accuracy of an infrared tympanic thermometer. Chest. 1999 Apr;115(4):1002-5. doi: 10.1378/chest.115.4.1002.

    PMID: 10208200BACKGROUND

  • Ao H, Moon JK, Tanimoto H, Sakanashi Y, Terasaki H. Jugular vein temperature reflects brain temperature during hypothermia. Resuscitation. 2000 Jul;45(2):111-8. doi: 10.1016/s0300-9572(00)00154-4.

    PMID: 10950319BACKGROUND

  • Baumgartner FJ, Janusz MT, Jamieson WR, Winkler T, Burr LH, Vestrup JA. Cardiopulmonary bypass for resuscitation of patients with accidental hypothermia and cardiac arrest. Can J Surg. 1992 Apr;35(2):184-7.

    PMID: 1562930BACKGROUND

MeSH Terms

Conditions

Epilepsy

Interventions

Thermometers

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 2001

First Posted

November 5, 2001

Study Start

November 1, 2001

Study Completion

April 1, 2003

Last Updated

March 4, 2008

Record last verified: 2003-04

Locations

US(1)