Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

Cionic

Status: Enrolling

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

Treatments: Behavioral: Walking Program; Device: Cionic Neural Sleeve NS-100

Study type: Interventional

Funder types: Industry

Identifiers

NCT05964829

CIONIC-06-001

Details and patient eligibility

About

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

Full description

The randomized within-participants crossover 12-week study aims to demonstrate the clinical impact of the Cionic Neural Sleeve for individuals diagnosed with MS.

Physical measurements, performance-based tests, and questionnaire responses will be recorded. These include physical activity recorded by the Cionic Neural Sleeve; in-person tests measuring disability, spasticity and balance; and questionnaires gauging perceived walking ability, quality of life, and physical and psychological impact of MS.

All participants will be assigned a Cionic Neural Sleeve on the most impacted leg for 6 weeks, and prescribed a home-based intervention of 15 minutes of walking for 5 days a week for 12 weeks. The Cionic Neural Sleeve will be worn for 6 weeks of the study while following the walking program.

Participants will be randomized to one of two groups: A or B. Group A will follow the walking program and wear the Neural Sleeve to receive stimulation assisted walking from the Neural Sleeve for 6 weeks. Group B will follow the walking program for 6 weeks. After 6 weeks, participants in each group will cross over to the other group.

Enrollment: 14 estimated patients

Sex: All

Ages: 22 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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14 participants in 2 patient groups

Control

Experimental group

Description:

Participants will follow the walking program.

Treatment:

Behavioral: Walking Program

Functional electrical stimulation

Experimental group

Description:

Participants will follow the walking program and receive stimulation assistance during the walking sessions.

Treatment:

Device: Cionic Neural Sleeve NS-100

Behavioral: Walking Program