Clinical trial NCT05964829: Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
Official title: A Crossover Study Evaluating the Impact of the Cionic Neural Sleeve on Mobility, Disability, Fall Risk, and Physical Activity in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Chronic Progressive
Lead sponsor: Cionic, Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-28
Enrollment: 14
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed description: The randomized within-participants crossover 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 an Actigraph; 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 hip-worn Actigraph activity monitor, a Cionic Neural Sleeve on the most impacted leg, and prescribed a home-based intervention of 15 minutes of walking for 5 days a week for 12 weeks. The Actigraph will be worn for the duration of the 12-week walking intervention, while the Cionic Neural Sleeve will be worn for 6 weeks of the study.

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

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

Primary outcomes:
measure: Change in Gait Speed
timeFrame: Week 1, Week 6, Week 12
measure: Change in Perceived Walking Ability
timeFrame: Week 1, Week 6, Week 12
measure: Change in MS Disability
timeFrame: Day 0, Week 6, Week 12
measure: Amount of Daily Walking/Activity Level
timeFrame: Day 0, from enrollment to end of treatment at 12 weeks, post-intervention at Week 16
measure: Duration of Daily Walking/Activity Level
timeFrame: Day 0, from enrollment to end of treatment at 12 weeks, post-intervention at Week 16
Secondary outcomes:
Other outcomes:
measure: Change in Health-Related Quality of Life
timeFrame: Day 0, Week 6, Week 12
measure: Change in Impact of MS
timeFrame: Day 0, Week 6, Week 12
measure: Change in Perceived Fatigue
timeFrame: Day 0, Week 6, Week 12
measure: Change in Spasticity
timeFrame: Week 1, Week 6, Week 12
measure: Change in Lower Limb Strength
timeFrame: Week 1, Week 6, Week 12
measure: Change in Ankle Plantarflexor Strength
timeFrame: Week 1, Week 6, Week 12
measure: Change in Lower Limb Range of Motion
timeFrame: Week 1, Week 6, Week 12
measure: Change in Walking Endurance
timeFrame: Week 1, Week 6, Week 12
measure: Change in Balance
timeFrame: Week 1, Week 6, Week 12
measure: Change in Incidence of Falls
timeFrame: From enrollment to end of treatment at 12 weeks, post-intervention at Week 16
measure: Change in Medication(s) and Dosage
timeFrame: Day 0, Week 1, Week 6, Week 12, post-intervention at Week 16
measure: Change in Pain
timeFrame: Week 1, Week 6, Week 12
measure: Change in Self-Reported Physical Activity
timeFrame: From enrollment to end of treatment at 12 weeks, post-intervention at Week 16
Locations:
city: Cleveland
country: United States
facility: Cleveland State University
state: Ohio
Study officials:
affiliation: Cleveland State University
name: Douglas A Wajda, PhD
role: PRINCIPAL_INVESTIGATOR
References: