Abstracts

Animal and human data suggest that cooling of the cortex changes its electrical behavior and may even stop seizures. We have previously demonstrated [Epilepsia 2003; 44(S9):33; A# 1.087.] the feasibility and safety of whole-head cooling of 60-minute duration in normal volunteers. Thus, to test to what extent the attained cooling is effective in treating seizures in patients with epilepsy, we designed a Phase II FDA pilot study. Five patients having at least one seizure per week as averaged over a 12-week pre-cooling period were recruited. For each of the four 60-minute weekly cooling sessions, patients were admitted to the hospital overnight. Five hours before cooling they swallowed a temperature sensor pill (HQ, Inc., Palmetto, FL) that measured intestinal temperature, used as an indicator of central core temperature (CT). Participants were then fitted with the elastic cooling helmet, comfortably seated in a reclining chair and covered with blankets to keep the body warm during cooling. Cooling was performed using a head-neck cooling system (CoolSystems, Inc., Lincoln, CA) [Epilepsia 2003;44(S9):33; A#1.087; J Neurosurg 2004;100,272-277]. EEG, pulse and O[sub]2 [/sub]saturation were monitored continuously, while external temperature was measured from multiple sites on the head (scalp, ears, face and mouth) and elsewhere (forearm, abdomen and leg) every 5 minutes. A 12-week post-cooling follow up period followed. The first patient (49, woman), who failed two right temporal lobectomies, experienced 1.25 seizures per week before cooling, 1.5 during cooling, and 0.75 during the 4 weeks after cooling. She tolerated cooling well, and on average, at the end of cooling, her CT was lowered by 0.25[deg]C, scalp temperature (ST) by 9.6[deg]C, right ear (RET) 3.15[deg]C and left ear (LET) 1.82[deg]C. The second patient (52, man with schizencephaly) experienced 0.75 seizures per week before cooling, 0 during cooling, and 1.25 after cooling. He also tolerated cooling well, and on average, at the end of cooling, his CT was lowered by 0.24[deg]C, ST by 14.7[deg]C, RET 2.25[deg]C and LET 1.85[deg]C. Three more patients have been enrolled and will soon begin cooling. Four weekly sessions of cooling were tolerated well by two treated patients. The first patient experienced a decrease in seizures after cooling, while the second experienced complete seizure control during cooling. Thus, head-neck cooling may be beneficial to some patients with intractable seizures. Potential confounding factors and the meaning of the results are discussed in anticipation of completion of the study. (Supported by the NINDS protocol 03-N-0272.)