Reducing Seizure Frequency Using Cooling of the Head and Neck

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.

- 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

Study Location
Maryland