A Multi-Center Controlled Study of the Acute and Chronic Effects of Cooling Therapy for Multiple Sclerosis.
|Title||A Multi-Center Controlled Study of the Acute and Chronic Effects of Cooling Therapy for Multiple Sclerosis.|
|Publication Type||Journal Article|
|Authors||Luna B, Schwid SR, Cutter GR, Murray R, Bowen JD, Pellegrino R, Guisado R, Webbon BW, Alquist AD, Harper-Bennie J, Ku Y-T, Lamparter R, Leitch J, Montgomery LD, Petrie MD|
Objective: To determine the acute and chronic effects of cooling therapy on patients with MS using objective functional performance measures and self-assessed measures of fatigue. Background: Cooling demyelinated nerves can reduce conduction block, potentially improving symptoms of MS. Significant acute and chronic effects of cooling have not been demonstrated in a multi-center, controlled, blinded study using objective measures of neurologic function. Design/Methods: Patients (N=84) with definite MS, mild to moderate disability (EDSS < 6.0), and self-reported heat sensitivity were enrolled at five study sites. Acute effects of cooling were assessed by randomly assigning subjects to high-dose or low-dose cooling for one hour using an active cooling vest and cap (Life Enhancement Technologies, Santa Clara, CA). settings were individualized to maintain the cooling garments at 55ºF for the high-dose treatment and 70ºF for the low-dose treatment. Both patients and examining investigators were blinded to treatment assignments. The MS Functional Composite (MSFC) and visual acuity/contrast sensitivity were assessed before and 30 minutes after treatment. One week later, subjects had an identical visit with the alternate cooling treatment. Chronic affects of cooling were assessed by randomly assigning the same subjects to unblended daily home cooling or observation for four weeks. All subjects completed the Rochester Fatigue Diary (RFD) twice weekly and subjectively evaluated their strength, cognitive ability, and energy level daily. At the end of the period, subjects crossed over to the alternate four-week treatment. Results: Oral temperatures were reduced with both acute treatments (0.8 ±0.06ºF, low). While mean MSFC did not change significantly during individual cooling sessions, post hoc analysis pooling the 3 high-dose cooling sessions revealed an improvement in MSFC scores from before to after cooling (0.055 ± 0.016, p = 0.0009). The change in MSFC scores during the acute cooling sessions was not related to the extent of change in oral temperatures. Both the RFD score and the MFIS indicate a significantly lower fatigue level during the cooling month compared to the observation month (RFD, 2.53 ±0.83, p = 0.0033; MFIS 7.63 ±1.56, p = 0.0001). Conclusions: Subjective improvements in fatigue and other symptoms were sustained during one month of home cooling treatment. MSFC scores improved during one month of home cooling treatment. MSFC scores improved during one-hour cooling sessions, but improvements were unrelated to the amount of cooling that subjects experienced.