What side effects are associated with this type of intervention?

Electrical stimulation treatments for Multiple Sclerosis, such as those similar to the Cionic Neural Sleeve, generally have mild side effects. These can include sensations of warmth, numbness, redness, itching, tingling, muscle spasms, and localized pain in areas such as the arm, shoulder, or neck. More broadly, common MS treatments like fingolimod can cause headaches, elevated liver enzymes, diarrhea, cough, flu-like symptoms, sinusitis, back pain, and abdominal pain. Serious side effects may include bradyarrhythmia, macular edema, liver injury, and increased risk of infections.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Sclerosis (MS) that focus on improving muscle function and coordination through electrical stimulation. One notable example is the use of functional electrical stimulation (FES) devices, which help improve mobility and reduce spasticity in MS patients. These devices work by delivering electrical impulses to nerves and muscles, thereby enhancing muscle strength and coordination. The Cionic Neural Sleeve, currently under study, is an example of such a device aimed at improving mobility in individuals with MS through targeted electrical stimulation.

What other types of research exist?

Promising alternatives to the Cionic Neural Sleeve for MS patients include: 1) Spinal Cord Stimulation (SCS), which has shown efficacy in various conditions involving nerve and muscle function. 2) Diaphragm Pacing, which, while primarily used for respiratory function, indicates the potential for neuromuscular improvement. 3) Sphenopalatine Ganglion (SPG) Stimulation, which has been shown to augment blood flow and improve neurologic function. These alternatives offer different mechanisms of action and may provide additional benefits for MS patients.

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Device

Cionic Neural Sleeve for Multiple Sclerosis

N/A

Waitlist Available

Led By Douglas A Wajda, PhD

Research Sponsored by Cionic, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0, week 1, week 6, week 12, post-intervention at week 16

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed, potential issues may include discomfort from wearing the sleeve, skin irritation, muscle fatigue from stimulation, or difficulty tolerating electrical stimulation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0, week 1, week 6, week 12, post-intervention at week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0, week 1, week 6, week 12, post-intervention at week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0, week 1, week 6, week 12, post-intervention at week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Amount of Daily Walking/Activity Level

Change in Fall Risk

Change in Gait Speed

+3 more

Other study objectives

Change in Ankle Plantarflexor Strength

Change in Balance

Change in Blood Glucose

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Functional electrical stimulationExperimental Treatment2 Interventions

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

Group II: ControlExperimental Treatment1 Intervention

Participants will follow the walking program.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Multiple Sclerosis (MS) include disease-modifying therapies (DMTs) that target the immune system to reduce inflammation and slow disease progression, and symptomatic treatments like physical therapy and medications to manage spasticity and pain. Electrical stimulation, such as the Cionic Neural Sleeve, works by sending electrical impulses to muscles to improve muscle function and coordination. This is particularly important for MS patients as it can enhance mobility, reduce muscle stiffness, and improve overall quality of life by addressing motor deficits directly.

Robot-based rehabilitation of the upper limbs in multiple sclerosis: feasibility and preliminary results.