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Home > "R" Clinical Trials Conditions > Reducing Seizure Frequency Using Cooling of the Head and Neck  Reducing Seizure Frequency Using Cooling of the Head and Neck
Reducing Seizure Frequency Using Cooling of the Head and Neck
For Condition: Seizures,Epilepsy
Status: Recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: 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.
Details: Previous experimental as well as clinical reports have clearly shown that cooling of the brain does have inhibitory effects on epileptiform discharges and seizures. We hypothesize that mild cooling of the brain has anti-epileptic effects in epileptic patients who either have no identifiable seizure foci, who have multiple foci, or who have frequent localization-related seizures that are refractory to antiepileptic drugs. We have studied the feasibility and safety of a head-neck cooling device in 10 adult normal volunteers, and found that the head-neck cooling was feasible and safe, without significant complaints or problems voiced by the subjects. Overall, a slight reduction of core temperature was shown. Since cooling on a twice-a-week basis was well tolerated by normal volunteers, we would like to extend our study to patients with epilepsy to learn the optimal duration and frequency of head-neck cooling in terms of reducing seizure frequency. This will be a pilot study, as directed by PIRC and the IRB, in which we will evaluate 60 minutes of cooling performed once a week for 4 weeks in 5 epileptic patients. We will then report the results to PIRC and the IRB before we proceed with further study.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: A body weight between 80 and 250 pounds. 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 No known or suspected obstructive diseases (i.e., ileus of various kinds) of the gastrointestinal tract including diverticulum and diverticulitis No history of inflammatory bowel disease. No history gastrointestinal surgery. No impairment of the gag reflex. No hypomotility disorders of the gastrointestinal tract including constipation. No plan for MRI examination and no proximity to strong magnetic fields within 2 weeks of the start of the study. No taking medication of any kind (other than anticonvulsants), including prescription, over the counter or herbal medicines for at least the past 3 months. Must be a non-smoker
Total Enrollment: 5
Location and Contact Information:
National Institute of Neurological Disorders and Stroke (NINDS) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030272; 03-N-0272
Study Start Date: August 11, 2003
Record last reviewed: August 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067210
Other Epilepsy Studies:
1. Activating Effects of Sleep Deprivation on Synchronized MEG-EEG Recordings of Epilepsy Patients with Non-Diagnostic EEG
2. Treatment Of Primary Generalized Tonic-Clonic Seizures With An Investigational New Drug
3. Infrared Camera for Brain Mapping During Surgery
4. Brain Infusion of Muscimol to Treat Epilepsy
5. Genetic Study of Familial Epilepsy
Related Studies:
Other Epilepsy Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Reducing Seizure Frequency Using Cooling of the Head and Neck
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