NCT05964829

Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis

A Crossover Study Evaluating the Impact of the Cionic Neural Sleeve on Mobility, Disability, Fall Risk, and Physical Activity in Multiple Sclerosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Cionic, Inc. · Industry
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Multiple Sclerosis, Chronic Progressive

Interventions

Type	Name	Description
DEVICE	Cionic Neural Sleeve NS-100	The Cionic Neural Sleeve applies functional electrical stimulation as subjects walk to help contract appropriate muscles at appropriate times. The Cionic Neural Sleeve will be worn for 6 weeks.
BEHAVIORAL	Walking Program	15 minutes of walking for 5 days per week for 6 weeks

Timeline

• Start date: 2023-09-04
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2023-07-28
• Last updated: 2025-09-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study