Neuro20 Suit for Neurological and Physical Impairments

(Neuro20 Trial)

Recruiting at 1 trial location

Overseen By Hannah Grimes

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brooks Rehabilitation

Disqualifiers: Cardiac disease, Cancer, Epilepsy, others

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

Compensation: Varies

Number of Visits: 12

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Neuro20 Functional Electrical Stimulation Suit to assess its effects on nerve function, muscle strength, and walking ability in individuals with an amputation or a neurologic injury, such as a stroke or spinal cord injury. The suit uses electrical pulses to improve movement patterns and muscle performance. Participants will wear the suit during therapy sessions over several weeks. This trial suits individuals who are at least one week post-injury or amputation and can follow simple instructions. As an unphased trial, it provides an opportunity to explore innovative rehabilitation methods that could enhance recovery outcomes.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Neuro20 Functional Electrical Stimulation Suit is safe for neurological and physical impairments?

Research has shown that the Neuro20 Functional Electrical Stimulation Suit is generally safe for use. The FDA has approved it for various purposes, such as muscle training, improving blood flow, and reducing muscle spasms, indicating that the suit is usually well-tolerated.

The technology is non-invasive and drug-free. It uses electrical signals to contract muscles without conscious effort, eliminating the need for surgery or medication and often reducing the risk of serious side effects.

Studies have not reported any serious side effects, though minor ones can occur. These might include skin irritation where the suit contacts the body, but such effects are usually manageable.

Overall, existing research and FDA approval suggest that the Neuro20 suit is a safe option for improving muscle and nerve function. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for neurological and physical impairments rely on traditional physical therapy or medications designed to manage symptoms. However, the Neuro20 Functional Electrical Stimulation Suit stands out because it directly stimulates muscles using electrical impulses to enhance therapy. This suit can switch between conditioning and strength modes, allowing for a tailored approach to rehabilitation. Researchers are excited because this method could potentially accelerate recovery and improve muscle function more effectively than existing options.

What evidence suggests that the Neuro20 Functional Electrical Stimulation Suit is effective for neurological and physical impairments?

Research has shown that the Neuro20 Functional Electrical Stimulation Suit could benefit individuals with neurological and physical challenges. Past users of functional electrical stimulation (FES) have experienced improved muscle performance and faster walking speeds. The Neuro20 Suit, which trial participants will use, stimulates muscles to enhance movement and strength. It has assisted those with conditions such as multiple sclerosis (MS), stroke, and spinal injuries. The suit may also positively affect the autonomic nervous system, which regulates heart rate and digestion. Although further research is needed, early results suggest it could be a valuable tool in rehabilitation. ^{2 3 6 7 8}

Who Is on the Research Team?

Mark Bowden, PT, PhD

Principal Investigator

Brooks Rehabilitation

Are You a Good Fit for This Trial?

This trial is for individuals who have experienced a stroke, spinal cord injury, or are amputees. The specific eligibility criteria to participate in the study are not provided.

Inclusion Criteria

I am over a week post-amputation or had a brain injury, stroke, or spinal injury and am stable enough for rehab.

I can understand and follow simple instructions.

Exclusion Criteria

Pregnancy

Implanted medical devices

Implanted stimulator or pump that cannot be turned off externally

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in therapy with the Neuro20 Functional Electrical Stimulation Suit. The first three sessions are in conditioning mode, followed by nine sessions in strength mode.

4 weeks

12 sessions (in-person)

Follow-up

Participants are monitored for changes in autonomic function and gait after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Neuro20 Functional Electrical Stimulation Suit

Trial Overview The trial is studying the effects of therapy sessions using the Neuro20 Functional Electrical Stimulation Suit on autonomic function, muscle performance, and walking ability in patients with neurological injuries or amputation.

How Is the Trial Designed?

Group I: Active Suit Stimulation Experimental Treatment 1 Intervention

Participants will be engaging in one hour of therapy with the suit in stimulation mode for twelve sessions. The first three sessions will be in conditioning mode, and the subsequent nine will be in strength mode.

Who Is Running the Clinical Trial?

Brooks Rehabilitation

Lead Sponsor

Trials

16

Recruited

1,900+

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/46/NCT07164846/Prot_000.pdf

Effect of Neuro20 Functional Electrical Stimulation Suit on ... We hypothesize that the Neuro20 suit will improve gait kinematics, gait speed, and muscle performance. Our secondary aim is to examine the ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT07164846/effect-of-neuro20-functional-electrical-stimulation-suit-on-autonomic-function-muscle-performance-and-gait

Effect of Neuro20 Functional Electrical Stimulation Suit on ... This research aims to understand the effect of the Neuro20 Functional Electrical Stimulation Suit on autonomic nervous system function, muscle ...

3. withpower.com withpower.com/trial/phase-stroke-7-2025-060d2

Neuro20 Suit for Neurological and Physical Impairments This research aims to understand the effect of the Neuro20 Functional Electrical Stimulation Suit on autonomic nervous system function, muscle performance, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10844914/

Effectiveness of functional electrical stimulation machine in ... Conclusion: FES cycling is an effective treatment for patients with neurological impairments, as it resulted in improvement in both upper and lower limb muscle ...

5. neuro20.com neuro20.com/

Neuro20: Transforming Lives with Technology - Neuro20 Neuro20 FDA cleared neuromuscular therapy transforms rehab, improving outcomes for MS, stroke, spinal injuries and more.

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K223797.pdf

February 23, 2023 Neuro20 Technologies Dave Yungvirt CEO ... The system utilizes electrical stimulation to create an involuntary contraction. The excitations of motor neurons are transmitted to the muscle.

7. odtmag.com odtmag.com/breaking-news/fda-clears-neuro20-pro-for-neuromuscular-injury-and-disease/

FDA Clears Neuro20 PRO for Neuromuscular Injury and ... The FDA cleared Neuro20 PRO for muscle re-education, increasing local blood circulation, maintaining or increasing range of motion, relaxation of muscle spasms.

8. neurorehabrecovery.com neurorehabrecovery.com/neuro20/?srsltid=AfmBOoqAOAx33QE8bZe4hQGTlUg9CbQwnY1gZbG80eJPjWkvtb8wTg7x

Neuro20 Neuro20 is a medical-grade system using a Smart Suit and software for neuro rehab, using EMS to improve recovery and neuroplasticity.