Can Exercise Combined with Cranial Nerve Non-Invasive Neuromodulation (CN-NINM) Improve Mobility in Non-Ambulatory People with MS? a Case Study Series

Background: Though growing evidence supports rehabilitation for people with multiple sclerosis, literature regarding effective interventions for those with advanced disease (AMS) is scarce. We have developed a novel intervention to improve balance and gait using Cranial Nerve Non-invasive Neuromodulation (CN-NINM) in conjunction with targeted physical therapy (PT).  In our fMRI study with subjects who have balance deficits due to primary vestibular dysfunction, traumatic brain injury, and spinocerebellar ataxia, the intervention created changes in localized brain activity levels, corresponding to improved balance, gait, mood, and sense of well-being.  Our randomized, controlled trial showed that CN-NINM with targeted PT improved balance and walking in ambulatory people with mild to moderate MS. The current study applies our intervention to people with advanced MS.

Objectives: Pilot study to determine if the CN-NINM intervention can improve balance, gait, and function in subjects with advanced MS; and to identify performance measures that are responsive in this population.

Methods: 6 subjects (EDSS 6.5-7.5) participated. All were assessed with the Repeatable Battery for the Assessment of Neuropsychological Status, Trunk Impairment Scale, video nystagmography, Multiple Sclerosis Impact Scale (MSIS-29), Modified Fatigue Impact Scale (MFIS), 12-item MS Walking Scale, Impact of Visual Impairment Scale, and Box & Blocks.   If applicable, the Medical Outcomes Study Pain Effects Scale, Bladder Control Scale, Bowel Control Scale, Walking Distance and Speed, Static Standing Balance Test, Gross Motor Function Measure, and Modified Rivermead Mobility Index were also assessed.  Subjects trained for two weeks in lab, and continued a home program that included twice daily 20-minute sessions of standing/sitting balance training, gait/pre-gait activity, breathing and awareness training, and movement exercise for 6 months (total 2 hours per day).  Subjects returned to the lab every 5th week for retraining and testing.

Results:  All subjects tolerated the intervention, with average home program compliance of >60% and no adverse events attributable to study participation.  Three of the 4 subjects with EDSS 6.5 – 7.0 improved their walking speed and/or distance, MFIS, and MSIS-29 scores. Subjects with EDSS 7.5 showed limited functional gains, but tolerated the physical activity of the protocol without adverse event.  The demanding CN-NINM regimen also resulted in significant real life improvements (re-adopting a walker for community mobility; overcoming physical obstacles at home to increase community access).

Conclusions: CNNINM is well tolerated by people with advanced MS.  Those with greater functional ability at the beginning of the study (EDSS 6.5 – 7.0) made the most significant functional gains.  For people at this level, the intervention shows promise to prolong functional ambulation and independence with daily activities.