Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

Inclusion Criteria:

• Persons with relapsing-remitting or progressive forms of MS between the ages of 22and 75

• Ability to ambulate at least 15 minutes throughout the day for five days per week,with or without assistive device

• Adequate cognitive and communicative function as assessed via Telephone Interviewfor Cognitive Status (TICS) to identify persons with dementia

• Able to tolerate the Neural Sleeve device for up to 8 hours per day

• T25FWT time between 8 and 45 seconds

• No recent change in medication or recent exacerbation of symptoms over the last 60days

• Patient-determined Disease Steps score between 3 and 5 or EDSS score between 4 and 6.5

Exclusion Criteria:

• Lower motor neuron disease or injury (e.g. peripheral neuropathy) that may impairresponse to stimulation

• Absent sensation in the impacted or more impacted leg

• Inadequate response to stimulation, defined by inability to achieve musclecontraction or unable to tolerate stimulation

• Inability to ambulate with the sleeve in place of an ankle foot orthosis (AFO)/kneeankle foot orthosis (KAFO) if utilized

• History of falls greater than once a week

• No use of FES devices in the past year

• Demand-type cardiac pacemaker or defibrillator

• Malignant tumor in the impacted or more impacted leg

• Existing thrombosis in the impacted or more impacted leg

• Fracture or dislocation in the impacted or more impacted leg that could be adverselyaffected by motion from stimulation