Protocol Number: 03-N-0272

Title:

Cooling of the Head and Neck to Reduce Seizure Frequency: A Pilot Study

Number:

03-N-0272

Summary:

Doctors use cooling of the brain to help stop seizures. This procedure is usually accomplished through surgery. Cooling of the face and scalp may also cool the brain, avoiding the need for surgery.

The purpose of this study is to assess a head-neck cooling device that the patient can wear. Researchers will determine whether the device can change the frequency of seizures in people with epilepsy.

Study participants must be 21 years of age or older and must experience seizures that occur once a week on a regular basis. Participants will be asked to keep a detailed seizure diary for a 12-week period before the date of the first cooling session. For each of the four cooling sessions, participants will be admitted to the hospital overnight. They will undergo a physical and neurological exam and an EEG (electroencephalogram). They will also swallow a temperature-sensor pill. Participants will have one 60-minute cooling session once a week for 4 weeks. Investigators will paste temperature-sensing electrodes on the scalp, forearm, abdomen, and leg. Participants will then be fitted with the cooling unit and the session will begin.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

A minimum of one documented seizure of any type per a 1-week period.

21 years or older, and able to cooperate with the cooling procedures.

On a stable antiepileptic drug (AED) regimen, as determined by history and by AED plasma levels as measured in the CC OPD.

The ability to maintain a daily seizure calendar, either independently or with help from a family member.

No history of intestinal problems or history of intestinal surgery.

Must be able to swallow medication in capsule form.

EXCLUSION CRITERIA:

Female patients who are pregnant.

Those patients under 21 years of age.

Those patients who may have difficulty swallowing a large capsule, or describing their feelings and experiences related to the cooling sessions.

Those patients with a history of intestinal problems or intestinal surgery

Those patients with progressive neurological disorders

Those sensitive to coldness

History of severe (ice-cream) headache

Special Instructions: Currently Not Provided

Keywords:

Brain

Epilepsy

Core

Temperature

Recruitment Keywords:

Epilepsy

Conditions:

Epilepsy

Seizures

Investigational Drug(s):

None

Investigational Device(s):

Head and Neck Cooling System

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Aihara H, Okada Y, Tamaki N. The effects of cooling and rewarming on the neuronal activity of pyramidal neurons in guinea pig hippocampal slices. Brain Res. 2001 Mar 2;893(1-2):36-45.

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.

Cabanac M. Selective brain cooling in humans: "fancy" or fact?

FASEB J. 1993 Sep;7(12):1143-6; discussion 1146-7. Review.

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