Evaluating the Impact of the Cionic Neural Sleeve™ on Quality of Life in Multiple Sclerosis Patients: A Pilot Study

OBJECTIVES: Drugs alone achieve limited benefit for improving mobility in multiple sclerosis (MS) patients. This study evaluated the Quality of Life (QoL) of MS patients using the Cionic Neural Sleeve™ (Neural Sleeve), bionic clothing that combines motion analysis with sequential stimulation of up to four muscle groups in the upper and lower leg.

METHODS: We conducted a prospective, single site pilot study, recruiting five ambulatory adults with relapsing-remitting or progressive forms of MS. They were randomly assigned to two groups: Group A used the Neural Sleeve for 6 weeks, followed by 6 weeks without the Neural Sleeve. Group B had a 6-week period without the Neural Sleeve, followed by 6 weeks using the Neural Sleeve. Both groups had a 1-week baseline without the Neural Sleeve and a 4 week follow up. The EQ-5D-5L (EuroQol-5 Dimensions, 5-Level) was administered before and after use of the Neural Sleeve. The five dimensions of the EQ-5D were analyzed and weighted for the United States population.

RESULTS: The average EQ-5D score increased from 0.680 before the Neural Sleeve to 0.818 after the Neural Sleeve, resulting in an absolute change of 0.138 or 20.3% suggesting an improvement in QoL. Each dimension in the EQ-5D showed improvement with the Neural Sleeve. Mobility and Self-Care saw the most significant improvements, with the average rating improving 38.5% and 37.5%, respectively. The average Anxiety/Depression rating improved by 18.2%. Usual Activities and Pain improved by 10% and 12.5%, respectively. The improvement in the overall EQ-5D score was largely driven by Mobility, which accounted for 39.1% of the change in the total score.

CONCLUSIONS: Participants using the Cionic Neural Sleeve™ experienced improved QoL measures during the study. Physicians and payers need to consider the role of mobility improvement beyond treatment by drugs alone.