Reducing Seizure Frequency Using Cooling of the Head and Neck

NCT00067210 | Completed Phase 2

• 2 other identifiers: 03027203-N-0272
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy; Seizures

Keywords

Brain; Epilepsy; Core; Temperature

Outcome Measures

Primary Outcomes (1)

• Identify optimal cooling parameters,namely duration and frequency of cooling for reducing seizure frequency.

Interventions

Head and Neck Cooling System DEVICE

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Cabanac M. Selective brain cooling in humans: "fancy" or fact? FASEB J. 1993 Sep;7(12):1143-6; discussion 1146-7. doi: 10.1096/fasebj.7.12.8375612.

  PMID: 8375612 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 12, 2003
• First Posted: August 13, 2003
• Study Start: August 11, 2003
• Study Completion: May 22, 2007
• Last Updated: July 2, 2017

Record last verified: 2008-06-13

Locations

US (1)