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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 2, 2001 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | November 2001 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00025987 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Temperature Response to a Head-Neck Cooling System |
| Official Title ICMJE | Thermal Responses In Normal Volunteers To Head-Neck Cooling |
| 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. |
| 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 Phase | Phase I |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Safety Study |
| Condition ICMJE | Healthy |
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 10 |
| Completion Date | April 2003 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | 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 |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00025987 |
| Responsible Party | |
| Study ID Numbers ICMJE | 020025, 02-N-0025 |
| Study Sponsor ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | April 2003 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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