Neurosleeve for Arm Weakness/Paralysis

Not currently recruiting at 1 trial location

Overseen By Mijail Serruya, MD, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Must not be taking: Bupropion

Disqualifiers: Visual impairment, Orthopedic conditions, others

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

Compensation: Varies

Number of Visits: 45

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the NuroSleeve, a powered arm brace combined with a muscle stimulation system, can help individuals with arm weakness or paralysis regain movement for daily activities. Participants will use a custom NuroSleeve during occupational therapy sessions over eight weeks. The trial seeks participants who have experienced arm weakness due to a neurological condition or injury for at least six months and can move their arm somewhat but struggle with tasks like flexing the wrist or elbow. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that may enhance daily life for those with similar conditions.

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 prior data suggests that the NuroSleeve is safe for use in individuals with arm weakness or paralysis?

Research shows that the NuroSleeve, a powered arm brace with muscle stimulation, helps people with weak or paralyzed arms. This device uses electrical signals to move the arm. Studies of similar devices have found that electrical stimulation, such as TENS (Transcutaneous Electrical Nerve Stimulation), can reduce pain and improve muscle function.

Although specific safety data for the NuroSleeve is not yet available, similar devices using muscle stimulation are usually well-tolerated. Since this trial is in an early stage, the main goal is to assess the device's effectiveness rather than long-term safety. However, devices like this are generally tested for basic safety before use in people. If the NuroSleeve proves effective, it could greatly benefit those with arm weakness or paralysis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The NuroSleeve is unique because it combines a powered brace with a stimulation system to address arm weakness or paralysis, offering a new approach compared to traditional methods like physical therapy or passive braces. Unlike typical treatments that focus solely on exercise or support, the NuroSleeve actively stimulates muscles through electrical impulses, potentially enhancing muscle function more effectively. Researchers are excited because this dual-action system could lead to improved recovery outcomes and greater independence for patients with arm paralysis.

What evidence suggests that the NuroSleeve is effective for arm weakness or paralysis?

Research shows that the NuroSleeve Powered Brace & Stimulation System can improve movement in people with weak or paralyzed arms. This portable brace, combined with electrical stimulation, has restored arm movement. Participants in this trial will receive a customized NuroSleeve and undergo 8 weeks of occupational therapy using it. A study on the NuroSleeve highlighted its user-friendly design, which aids users in regaining some arm function necessary for everyday tasks. Early results suggest that this system may enhance arm health and increase independence for individuals with conditions like stroke or spinal cord injury. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• NuroSleeve Powered Brace & Stimulation System

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 report highlights the need for advanced neurotechnologies, such as bidirectional brain-computer interfaces, to restore motor and sensory functions in individuals with neurological conditions, emphasizing their potential to significantly enhance quality of life.

Key challenges identified include improving the interface between electrodes and tissue, developing smart implantable devices, and understanding how the brain adapts to these technologies, all of which are crucial for effective treatment of neurological disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Perspectives on Neuroengineering and Neurotechnologies: NSF-DFG Workshop Report. Moritz, CT., Ruther, P., Goering, S., et al.[2017]

Functional electrical stimulation (FES) provided greater or equal independence in mobility activities for children with motor-complete thoracic level spinal cord injuries compared to long leg braces (LLB), with 94% of comparisons showing less assistance needed with FES.

Children completed mobility tasks faster using FES, with significant time savings in two activities, and 62% of participants preferred FES over LLB, indicating a strong preference for this intervention.

NCBI (Pubmed)

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. Bonaroti, D., Akers, JM., Smith, BT., et al.[2019]

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]

Neuroprostheses (NPs) have evolved from early muscle stimulators to advanced devices that can effectively activate paralyzed muscles, with functional electrical stimulation (FES) showing significant benefits in enhancing muscle function, particularly in conditions like foot drop.

Recent advancements in technology have made these devices more convenient and reliable, leading to improved therapeutic outcomes, although challenges remain in enhancing upper limb function compared to lower limbs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor Neuroprostheses. Prochazka, A.[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 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]

The NuroSleeve, a user-centered hybrid orthosis combining a 3D-printed motorized device and functional electrical stimulation, was successfully used by participants to perform activities of daily living (ADLs) independently, demonstrating its practicality and ease of use.

Participants showed significant improvements in their Canadian Occupational Performance Measure (COPM) scores, indicating enhanced functional ability, while the device met safety and feasibility goals, suggesting it effectively addresses limitations of existing upper extremity assistive devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The NuroSleeve, a user-centered 3D printed hybrid orthosis for individuals with upper extremity impairment. Khantan, M., Avery, M., Aung, PT., et al.[2023]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04798378

NuroSleeve Powered Brace & Stimulation System to ... The purpose of this study is to investigate if a person with weakness or paralysis in one or both arms, can use the NuroSleeve combined powered arm brace ...

2. clinicaltrial.be clinicaltrial.be/en/details/46394?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

NuroSleeve Powered Brace & Stimulation System to Restore... Portable powered braces and functional electrical stimulation can help restore functional arm movement in these individuals. Powered braces and muscle ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10403889/

The NuroSleeve, a user-centered 3D printed hybrid ... This study introduces the design, implementation, and clinical evaluation of the NuroSleeve, a user-centered hybrid device that incorporates a ...

4. neurorestoration.jefferson.edu neurorestoration.jefferson.edu/programs-clinical-trials/nurosleeve-trial.html

NuroSleeve Trial - Raphael Center for Neurorestoration Participants may have arm weakness or paralysis due to conditions such as stroke, spinal cord injury, ALS, muscular dystrophy, and cerebral palsy.

5. scholarworks.wmich.edu scholarworks.wmich.edu/cgi/viewcontent.cgi?article=2166&context=ojot

Outcomes of the NuroSleeve and Occupational Therapy on ... This case report investigates the process and outcomes of occupational therapy (OT) for training in the use of the. NuroSleeve, a novel research ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04798378/nurosleeve-powered-brace-stimulation-system-to-restore-arm-function

NuroSleeve Powered Brace & Stimulation System to ... The purpose of this study is to investigate if a person with weakness or paralysis in one or both arms, can use the NuroSleeve combined ...

7. withpower.com withpower.com/trial/phase-cerebral-palsy-3-2021-2b07e

Neurosleeve for Arm Weakness/Paralysis This trial is testing the NuroSleeve, a wearable device that helps people with weak or paralyzed arms move them using electrical signals.