Cionic Neural Sleeve for Multiple Sclerosis

Overseen By Douglas A Wajda

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cionic, Inc.

Disqualifiers: Peripheral neuropathy, Absent sensation, Cardiac pacemaker, Malignant tumor, Thrombosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 12 weeks

14 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests the Cionic Neural Sleeve, a device that helps people with MS walk better by sending small electrical signals to their leg muscles. It targets individuals with MS who have trouble walking. The study will measure how well the device improves walking ability and quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that there should be no recent change in medication over the last 60 days. This suggests that you should maintain your current medication regimen without changes.

How does the Cionic Neural Sleeve treatment for Multiple Sclerosis differ from other treatments?

The Cionic Neural Sleeve is unique because it uses a non-invasive neural interface to stimulate peripheral nerves, potentially improving mobility in people with Multiple Sclerosis. This approach is different from traditional drug therapies as it focuses on enhancing nerve function through electrical stimulation rather than altering the immune system or inflammation. ^{1 2 3 4 5}

Research Team

Douglas A Wajda, PhD

Principal Investigator

Cleveland State University

Eligibility Criteria

This trial is for adults aged 22-75 with relapsing-remitting or progressive multiple sclerosis who can walk at least 15 minutes a day and have moderate mobility impairment. They should not have had medication changes or symptom exacerbation in the last 60 days, and must be able to wear the Neural Sleeve for up to 8 hours daily.

Inclusion Criteria

My mental ability to communicate and understand is confirmed to be adequate.

I can walk for at least 15 minutes daily, with or without help.

My medications and symptoms have been stable for the last 60 days.

Exclusion Criteria

Demand-type cardiac pacemaker or defibrillator

No use of FES devices in the past year

I have a condition like peripheral neuropathy that affects my muscle response.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to wear an Actigraph and a Cionic Neural Sleeve, with a home-based walking intervention for 12 weeks

12 weeks

Weekly monitoring visits

Crossover

Participants switch groups after 6 weeks to either receive stimulation assistance or continue with the Actigraph only

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Post-intervention assessment at Week 16

Treatment Details

Interventions

• Actigraph accelerometer
• Cionic Neural Sleeve NS-100

Trial Overview The study tests the Cionic Neural Sleeve NS-100's effectiveness on mobility in MS patients. Participants will use this device alongside an Actigraph accelerometer to measure movement benefits over time.

Participant Groups

Group I: Functional electrical stimulation Experimental Treatment 2 Interventions

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

Group II: Control Experimental Treatment 1 Intervention

Participants will follow the walking program.

Who Is Running the Clinical Trial?

Cionic, Inc.

Lead Sponsor

Trials

5

Recruited

130+

Findings from Research

This review outlines a comprehensive framework for translating neural interfaces for electrical modulation of the peripheral nervous system (PNS) from design to clinical use, emphasizing the importance of following FDA guidelines for safety and efficacy.

Key steps in the translational process include quantitative human anatomy, neural modeling, acute testing, and chronic deployment, with case studies demonstrating successful applications of specific electrode designs like the spiral cuff and Flat Interface Nerve Electrode (FINE).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A translational framework for peripheral nerve stimulating electrodes: Reviewing the journey from concept to clinic. Charkhkar, H., Christie, BP., Pinault, GJ., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Chronic measurement of the stimulation selectivity of the flat interface nerve electrode. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Neuroprosthetic effect of peroneal nerve stimulation in multiple sclerosis: a preliminary study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Biocompatibility of a silicon based peripheral nerve electrode. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A translational framework for peripheral nerve stimulating electrodes: Reviewing the journey from concept to clinic. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Brain plasticity after implanted peroneal nerve electrical stimulation to improve gait in chronic stroke patients: Two case reports. [2018]