Neurosleeve for Arm Weakness/Paralysis

Recruiting in Palo Alto (17 mi)

+1 other location

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Thomas Jefferson University

Must not be taking: Bupropion

Disqualifiers: Visual impairment, Orthopedic conditions, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing the NuroSleeve, a wearable device that helps people with weak or paralyzed arms move them using electrical signals. It is aimed at those who haven't fully recovered with standard therapies. The device detects small muscle movements and uses them to activate the brace and stimulate muscles, helping with arm movement. Electrical stimulation has been explored in various contexts, including improving arm and hand function in individuals with spinal cord injuries and post-stroke patients.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking bupropion and wish to undergo optional transcranial magnetic stimulation, you would be excluded from that part of the study.

What data supports the effectiveness of the NuroSleeve Powered Brace & Stimulation System for arm weakness or paralysis?

The NuroSleeve is designed to help people with arm weakness by providing support and electrical stimulation to improve movement. Similar devices, like powered orthoses and functional electrical stimulation systems, have shown potential in helping people with paralysis regain some movement, suggesting that the NuroSleeve could be effective for arm weakness as well. ^{1 2 3 4 5}

Is the Neurosleeve for Arm Weakness/Paralysis safe for humans?

Functional electrical stimulation (FES), which is similar to the technology used in the Neurosleeve, has been used in various applications and is generally considered safe, though it can cause muscle fatigue. The technology has been used for many years to help with movement in people with spinal cord injuries, and while it shows promise, it still requires careful application and monitoring. ^{3 6 7 8 9}

How is the NuroSleeve Powered Brace & Stimulation System different from other treatments for arm weakness or paralysis?

The NuroSleeve Powered Brace & Stimulation System is unique because it combines a powered orthosis (a supportive device) with functional electrical stimulation (FES), which uses electrical impulses to activate muscles and improve movement. This dual approach aims to enhance muscle function and support voluntary movements, offering a novel method compared to traditional therapies that may not integrate both mechanical support and electrical stimulation. ^{4 5 7 10 11}

Research Team

Eligibility Criteria

This trial is for individuals aged 4 or older with arm weakness or paralysis due to neurological diseases, injuries, or orthopedic conditions that occurred over 6 months ago. Participants must be medically stable, able to consent (or have a guardian who can), speak English, and follow trial instructions without skin conditions affecting electrical current application. They should not have implanted medical devices, excessive spasticity/pain in arms, metal implants in the affected arm, severe visual impairment even with lenses, untreated psychiatric/neurological issues affecting participation.

Inclusion Criteria

The participant is fluent in English and, if the participant were a child, at least one parent/guardian were fluent in English

I don't have any health issues that limit my leg movement or understanding of instructions.

I am medically stable and live at home.

Exclusion Criteria

Advice from any of the participant's health providers that upper extremity powered orthotics or electrical stimulation were contra-indicated

Your vision is so poor that it would be hard for you to follow instructions even with glasses or contact lenses.

Untreated psychiatric or neurologic disturbances that would affect motivation and trial participation

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a customized NuroSleeve and undergo 8 weeks of occupational therapy using the NuroSleeve

8 weeks

Sessions can be 45 minutes three times per week, 68 minutes twice per week, or one 135 minute session once per week

Follow-up

Participants are monitored for changes in arm function and occupational performance after treatment

4 weeks

Treatment Details

Interventions

• NuroSleeve Powered Brace & Stimulation System (Other)

Trial Overview The NuroSleeve study tests whether a powered brace combined with muscle stimulation can help restore arm movement sufficient for daily activities in people with arm weakness or paralysis. The goal is to develop a device like NuroSleeve to improve independent function and arm health.

Participant Groups

Group I: Treatment Arm Experimental Treatment 1 Intervention

Participants will received a customized NuroSleeve and undergo 8 weeks of occupational therapy using the NuroSleeve (135 minutes per week for 8 weeks: this can be done as 45 minutes three times per week, 68 minute sessions twice per week, or one 135 minute once per week).

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Dr. Eugene Kennedy

Thomas Jefferson University

Chief Medical Officer since 2020

MD

Dr. Joseph G. Cacchione

Thomas Jefferson University

Chief Executive Officer since 2022

MD, MBA

Findings from Research

Powered gait orthoses effectively induce movement in the lower limb joints of individuals with spinal cord injuries, improving walking mechanics and reducing strain on upper body muscles during ambulation.

While these devices enhance gait parameters, the impact on muscle activity remains uncertain, indicating a need for further research to optimize their design and functionality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of powered orthoses on walking in persons with paraplegia. Arazpour, M., Hutchins, SW., Ahmadi Bani, M.[2015]

Functional electrical stimulation (FES) can effectively increase muscle bulk and enable standing through bilateral stimulation of the quadriceps, but its clinical applications are limited and primarily conducted in research settings due to the lack of FDA-approved devices for standing.

Current FES systems are mostly open-loop, meaning they deliver predetermined stimulation patterns without feedback, and while implantable systems are not yet viable, hybrid systems like the reciprocating gait orthosis (RGO) are available, though their long-term benefits and user acceptance are still under evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower extremity applications of functional neuromuscular stimulation. Jaeger, RJ.[2005]

Fabric electrodes integrated into garments for functional electrical stimulation show potential as a comfortable alternative to traditional gel electrodes, although they require consistent moisture for effective use.

Initial tests indicated that while fabric electrodes had a lower sensory threshold, they also had a higher maximal stimulation threshold, suggesting that further design improvements are needed to enhance usability and effectiveness for individuals with neurological paralysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Garments for functional electrical stimulation: Design and proofs of concept. Moineau, B., Marquez-Chin, C., Alizadeh-Meghrazi, M., et al.[2022]

The transcutaneous functional neuromuscular stimulation (FNS) system, approved by the FDA in 1994, enables certain paraplegics to walk short distances independently without braces, demonstrating its efficacy in improving mobility.

The paper outlines important factors for patient acceptance and training, as well as discussing the system's limitations and potential areas for enhancement, highlighting the need for ongoing improvements in the technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous functional neuromuscular stimulation of certain traumatic complete thoracic paraplegics for independent short-distance ambulation. Graupe, D., Kohn, KH.[2019]

The hybrid functional-electrical stimulation (FES) gait system, which includes a computer-controlled orthosis, significantly reduces muscle fatigue and improves movement control compared to traditional FES alone, as shown in a study with four subjects with paraplegia.

By using controllable friction brakes at the hip and knee joints, the system allows for better regulation of limb trajectories and provides necessary support during stance, although further hardware design improvements are needed for practical use outside the lab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary evaluation of a controlled-brake orthosis for FES-aided gait. Goldfarb, M., Korkowski, K., Harrold, B., et al.[2006]

The controlled-brake orthosis (CBO) combines functional electrical stimulation (FES) with a long-leg brace to reduce muscle fatigue and improve gait performance in individuals with spinal cord injury, as shown in preliminary tests with one subject.

Initial results indicate that the CBO allows for more consistent gait trajectories compared to traditional FES systems, suggesting it could enhance mobility for a broader range of spinal cord injury patients, although further testing is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a controlled-brake orthosis for FES-aided gait. Goldfarb, M., Durfee, WK.[2019]

The functional electrical stimulation (FES) system for helping spinal cord injured patients walk includes adjustable components like muscle stimulators and a gait orthosis, allowing for personalized configurations for each patient.

The electrode delivery system, which is a key part of the FES setup, has been successfully used on patients with different levels of spinal cord injury, demonstrating its effectiveness in facilitating ambulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systems approach to medically prescribed functional electrical stimulation. Ambulation after spinal cord injury. Phillips, CA., Hendershot, DM.[2004]

References

1. England pubmed.ncbi.nlm.nih.gov

The NuroSleeve, a user-centered 3D printed hybrid orthosis for individuals with upper extremity impairment. [2023]

2. France pubmed.ncbi.nlm.nih.gov

The efficacy of powered orthoses on walking in persons with paraplegia. [2015]

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

Lower extremity applications of functional neuromuscular stimulation. [2005]

4. England pubmed.ncbi.nlm.nih.gov

Garments for functional electrical stimulation: Design and proofs of concept. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Transcutaneous functional neuromuscular stimulation of certain traumatic complete thoracic paraplegics for independent short-distance ambulation. [2019]

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

Preliminary evaluation of a controlled-brake orthosis for FES-aided gait. [2006]

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

Motor Neuroprostheses. [2019]

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

Comparison of functional electrical stimulation to long leg braces for upright mobility for children with complete thoracic level spinal injuries. [2019]

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

Design of a controlled-brake orthosis for FES-aided gait. [2019]

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

New Perspectives on Neuroengineering and Neurotechnologies: NSF-DFG Workshop Report. [2017]

11. England pubmed.ncbi.nlm.nih.gov

A systems approach to medically prescribed functional electrical stimulation. Ambulation after spinal cord injury. [2004]