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Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

RecruitingNA

Sponsor: Cionic, Inc.

Conditions: Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic Progressive

Interventions: Cionic Neural Sleeve NS-100, Walking Program

Countries: United States

The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).

Eligibility overview

Sex: ALL

Age: 22 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Persons with relapsing-remitting or progressive forms of MS between the ages of 22 and 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 Interview for 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 60 days
* 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 impair response to stimulation
* Absent sensation in the impacted or more impacted leg
* Inadequate response to stimulation, defined by inability to achieve muscle contraction or unable to tolerate stimulation
* Inability to ambulate with the sleeve in place of an ankle foot orthosis (AFO)/knee ankle 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 adversely affected by motion from stimulation

Locations (1)

Cleveland, Ohio, United States