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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Cionic Neural Sleeve to determine if it improves walking in people with multiple sclerosis (MS). Participants will either follow a walking program alone or with additional electrical stimulation during their walks. It suits individuals with MS who can walk for at least 15 minutes daily and have not experienced any major recent changes in their condition. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance mobility for those with MS.

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.

What prior data suggests that the Cionic Neural Sleeve is safe for individuals with multiple sclerosis?

Research has shown that the Cionic Neural Sleeve NS-100 is generally well-tolerated by users. It employs functional electrical stimulation to assist muscle movement. Some users have reported issues, but these are not due to any defect in the device itself.

The device is safe and easy to use in both clinics and at home. However, individuals with certain medical implants, such as specific heart devices, should avoid using the sleeve, as it may pose risks for them.

Overall, the FDA has approved the sleeve, indicating that it meets certain safety standards, which can reassure potential users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cionic Neural Sleeve for multiple sclerosis because it offers a novel approach to improving mobility. Unlike standard treatments that mainly focus on managing symptoms with medications like corticosteroids and immune-modulating therapies, the Neural Sleeve uses functional electrical stimulation to directly assist with movement. This wearable device provides targeted stimulation during walking sessions, potentially enhancing muscle coordination and strength. By integrating this technology into a walking program, it could offer a more direct and effective way to improve gait and mobility, which are major challenges for individuals with multiple sclerosis.

What evidence suggests that the Cionic Neural Sleeve is effective for multiple sclerosis?

Research has shown that the Cionic Neural Sleeve NS-100, which participants in this trial may receive, can help people with multiple sclerosis (MS) walk better. This device uses electrical signals to assist leg muscles in moving more effectively. It specifically aids ankle movement, improving foot drop—a common issue in MS where the front of the foot drags. Early results also suggest it reduces unwanted foot turning, making walking smoother and safer. This improvement could lead to fewer falls and easier movement for those with MS. ^{2 6 7 8 9}

Who Is on the Research Team?

Douglas A Wajda, PhD

Principal Investigator

Cleveland State University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05964829

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

2. neurologylive.com neurologylive.com/view/using-cionic-neural-sleeve-alleviate-gait-dysfunction-multiple-sclerosis-douglas-wajda

Using the Cionic Neural Sleeve to Alleviate Gait ... An early-stage study assessing the impacts of a functional electrical stimulation approach to treat gait problems in multiple sclerosis.

3. cionic.com cionic.com/science

Multi-Site Foot Drop Study Scientifically validated: Cionic Neural Sleeve improves ankle dorsiflexion and reduces inversion through adaptive stimulation—real-time gait ...

4. withpower.com withpower.com/trial/phase-multiple-sclerosis-8-2023-8700e

Cionic Neural Sleeve for Multiple Sclerosis 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.

5. trial.medpath.com trial.medpath.com/clinical-trial/8507c3d430737241/nct05964829-cionic-neural-sleeve-mobility-disability-fall-risk-physical-activity-multiple

Impact of the Cionic Neural Sleeve on Mobility in Multiple ... The randomized within-participants crossover study aims to demonstrate the clinical impact of the Cionic Neural Sleeve for individuals diagnosed with MS.

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=19601258&pc=GZI

MAUDE Adverse Event Report: CIONIC INC CIONIC NEURAL ... Is this an Adverse Event Report? Yes. Is this a Product Problem Report? No. Device Operator, Lay User/Patient. Device Model Number, NS-100.

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=21071146&pc=GZI

MAUDE Adverse Event Report: CIONIC FACILITY NEURAL ... I received a cionic neural sleeve in (b)(6) 2023.This is an fda approved device that uses ai(artificial intelligence) and functional electric stimulation to ...

8. support.cionic.com support.cionic.com/hubfs/CIONIC_NS-100_InstructionsForUse.pdf

Instructions The Cionic Neural Sleeve NS-100 is intended to be used in a clinical or home use setting. Contraindications. • Individuals with implanted demand-type cardiac.

9. nationalmssociety-org.clinicaltrialconnect.com nationalmssociety-org.clinicaltrialconnect.com/trials/NCT05964829

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