Preliminary evaluation of lowering tympanic temperature for the symptomatic treatment of multiple sclerosis

Objective: Two pilot studies were designed to assess the effects of acute cooling in the laboratory (experiment one) and daily home cooling (experiment two) on objective indices of MS impairment and disability. Methods: Experiment one was a single group, repeated measures design in which nine MS outpatients with a history of heat lability were tested for immediate effects of lowering tympanic temperature in the laboratory. Subjects were tested under three experimental conditions separated by about one week: cooling with each of two cooling garments (the Life Support Systems, Inc., Mark VII MicroClimate System(TM) and the SteeleVest(TM) Body Cooling System) and no cooling. Experiment two was a prospective, unblinded, parallel group study in which twelve chronic progressive MS outpatients with a history of heat lability entered a six-week cooling protocol. Subjects used a cooling suit at home to lower body temperature two times per day. Five additional MS patients were in a non-cooling control group. In both experiments subjects were evaluated by clinical, neuroperformance, and quality of life indices, and were tested with a reduced battery of indices immediately before and after cooling on their weekly visit to the laboratory. Results: In experiment one, significant temperature decreases (mean 0.6 degrees C) were achieved with both cooling garments, but no statistically significant change in performance post-cooling was found on any test measure. In experiment: two, eight out of twelve subjects reported reduced fatigue and improved ability to ambulate immediately after and up to two to three hours after cooling. There was a significant immediate post-cooling (non-cumulative) improvement on tandem gait and standing balance. Additionally, seven subjects reported long-term improvements in quality of life over the cooling weeks. No statistically significant cumulative effect of cooling was found on objective indices of motor and cognitive function. Conclusions: The results provided weak subjective support for both acute and cumulative effects of cooling. A placebo effect cannot be ruled out. The study raised important questions regarding development of an appropriate sham cooling procedure, measurement of core temperature changes, and other design issues in evaluating cooling in MS patients.