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NCT00025987 · ClinicalTrials.gov registry record · Phase 1

Temperature Response to a Head-Neck Cooling System

A Phase 1 study of Healthy, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

Completed
Registry status
Phase 1
Development phase
10
Enrollment target
1
Study location

NCT00025987 is a Phase 1 study of Healthy that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 10 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00025987, a Phase 1 study of Healthy, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

COMPLETED
Registry status
Phase 1
Development phase
10 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Healthy

Interventions

  • DEVICE Head and Neck Cooling System
  • DEVICE Thermometer Pill

Study Locations (1)

Maryland

  • National Institute of Neurological Disorders and Stroke (NINDS) - Bethesda

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2001-11
Est. Completion 2003-04
Phase Phase 1

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

567 total trials

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What the Registry Record Tells You About NCT00025987

The ClinicalTrials.gov registry entry for NCT00025987 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (98% lower). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Head and Neck Cooling System is the first listed.

NCT00025987 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00025987 about?

NCT00025987 is a clinical study titled "Temperature Response to a Head-Neck Cooling System". 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 work...

What is the current status of trial NCT00025987?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2001-11. Estimated completion is 2003-04.

What conditions does trial NCT00025987 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT00025987?

The interventions under investigation include: Head and Neck Cooling System (DEVICE), Thermometer Pill (DEVICE).

Who is sponsoring clinical trial NCT00025987?

This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00025987 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.