Stimulator Implant for Stroke Recovery

Recruiting at 1 trial location

Overseen By Nathan Makowski

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MetroHealth Medical Center

Disqualifiers: Non-English, Low bone density, Cardiovascular, Uncontrolled diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device designed to help stroke survivors improve their walking ability. The process involves implanting a stimulator (IRS-8), setting it up for home use, and monitoring its effects over several months. It suits individuals who had a stroke over six months ago, can walk with some assistance, and struggle with slow walking speeds. Participants must have stable health conditions and be prepared for follow-up appointments.

As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance rehabilitation options for stroke survivors.

Will I have to stop taking my current medications?

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

What prior data suggests that this implanted stimulator is safe for stroke recovery?

Research shows that functional electrical stimulation (FES), such as the IRS-8 device, has been used in individuals with neurological disorders, including those recovering from a stroke. Although specific safety data for the IRS-8 is unavailable, studies have found FES to improve physical abilities and consider it safe.

For the IST 12 and IST 16 devices, research on brain-computer interfaces (BCIs) has shown promise in aiding stroke recovery. BCIs use brain signals to control external devices, which can enhance movement skills. While specific safety data for IST 12 and IST 16 is lacking, BCIs have been used safely in stroke recovery.

Overall, these treatments are undergoing testing to confirm their safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Stimulator Implant for Stroke Recovery because it offers a novel approach to rehabilitation by directly stimulating the nervous system. Unlike traditional stroke recovery methods that often rely on physical therapy and medication, this implant is designed to facilitate walking by creating advanced controllers tailored to the individual's needs. This innovative technique aims to enhance recovery by providing continuous, targeted stimulation, potentially leading to more effective and faster improvements in mobility for stroke survivors.

What evidence suggests that this stimulator implant is effective for stroke recovery?

Research has shown that devices like IRS-8, implanted in the body, help stroke survivors walk better by sending electrical signals to stimulate muscles. This trial will evaluate IRS-8, which uses functional electrical stimulation (FES) to enhance walking ability and speed. Additionally, the trial will study IST 12 and IST 16, brain-computer interfaces (BCIs) that have helped stroke patients regain movement by connecting brain signals to external devices. Together, these methods offer hope for improving mobility in stroke survivors. ^{2 4 6 7 8}

Who Is on the Research Team?

Nathan Makowski, PhD

Principal Investigator

MetroHealth System, Ohio

Are You a Good Fit for This Trial?

This trial is for stroke survivors aged 21-75 who walk slower than normal due to the stroke. They should be at least 6 months post-stroke, have certain levels of muscle stiffness and motor function, and not need more than one person's help to walk. Participants must also be neurologically stable, speak English, not pregnant, without severe cognitive issues or medical conditions that increase fall risk.

Inclusion Criteria

I can walk with help from no more than one person.

My leg and lower back muscles respond normally to stimulation.

Willingness to comply with follow-up procedures

Exclusion Criteria

I have complications from a stroke that make me more likely to fall.

I have severe bone or joint issues like scoliosis or dislocations.

I have severe difficulties in thinking and communicating.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation, Controller Development, and Evaluation

Participants undergo surgery to implant a stimulator and electrodes, followed by training to use the device for walking assistance. Advanced controllers for walking are developed and evaluated over several months.

44 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations at 18 and 44 weeks post-implant.

44 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IRS-8
• IST 12 & IST 16

Trial Overview The study tests an implanted stimulator device designed to improve walking in people with gait disorders after a stroke. It involves screening candidates for eligibility, implanting the device, setting up home use controllers for walking improvement and evaluating its effects over several months.

How Is the Trial Designed?

Group I: Implantation, controller development, and evaluation Experimental Treatment 2 Interventions

This phase includes installing the device and setting the individual up for home use, creating advanced controllers for walking and evaluating the effect of the device over several months.

IRS-8 is already approved in United States for the following indications:

Approved in United States as IRS-8 for:

• Improving walking in stroke survivors

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+

Cleveland State University

Collaborator

Trials

14

Recruited

3,500+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

Louis Stokes VA Medical Center

Collaborator

Trials

21

Recruited

4,100+

Published Research Related to This Trial

The recoveriX system, which integrates a brain-computer interface with functional electrical stimulation and visual feedback, was tested on two chronic stroke patients, showing promising results in motor rehabilitation.

After 10 training sessions, one patient regained partial control of wrist extension, while the other improved finger movement, indicating the system's potential for enhancing motor recovery in paralyzed patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain-Computer Interfaces With Multi-Sensory Feedback for Stroke Rehabilitation: A Case Study. Irimia, DC., Cho, W., Ortner, R., et al.[2018]

Brain-computer interfaces (BCIs) show promise in motor rehabilitation by directly accessing brain information to help reintegrate the sensory-motor loop, which is crucial for treating neurological disorders that conventional medications cannot address.

Recent research indicates a trend towards developing implantable BCI devices that combine both BCI technology and stimulation systems, although this field is still in its early stages, particularly for post-stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor imagery based brain-computer interfaces: An emerging technology to rehabilitate motor deficits. Alonso-Valerdi, LM., Salido-Ruiz, RA., Ramirez-Mendoza, RA.[2019]

The study found that the wearable integrated volitional control electrical stimulation (WIVES) device is as effective as the conventional integrated volitional control electrical stimulation (IVES) device in improving upper extremity function in patients with paresis after stroke, with both groups showing significant improvements in the Fugl-Meyer Assessment of the upper extremity.

WIVES treatment demonstrated a mean improvement of 6.0 in the Fugl-Meyer Assessment, indicating that this more portable device can effectively support rehabilitation in daily life without compromising efficacy compared to the traditional device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Integrated Volitional Control Electrical Stimulation Device as Treatment for Paresis of the Upper Extremity in Early Subacute Stroke Patients: A Randomized Controlled Non-inferiority Trial. Maeda, H., Hishikawa, N., Sawada, K., et al.[2023]

Brain-computer interface (BCI) training significantly improves motor function recovery in stroke patients, with a standardized mean difference (SMD) of 0.39 for upper extremity recovery and 0.41 for lower extremity recovery compared to conventional therapy alone, based on a meta-analysis of 14 studies involving 362 patients.

BCI training also enhances brain function recovery, showing a strong effect with an SMD of 1.11, indicating its potential as a valuable addition to rehabilitation strategies for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of brain-computer interface training based on non-invasive electroencephalography using motor imagery on functional recovery after stroke - a systematic review and meta-analysis. Kruse, A., Suica, Z., Taeymans, J., et al.[2020]

A systematic review of 75 studies on noninvasive electrical stimulation (ES) in stroke recovery found that adverse events were mostly minor, with tingling being the most common at 18.1% prevalence among participants.

While some adverse events like itching and discomfort were associated with specific stimulation parameters, the overall safety profile of ES appears favorable, with only two severe adverse events reported, indicating it can be a safe therapeutic option for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Adverse Events following Non-invasive Electrical Brain Stimulation in Stroke: A Systematic Review. Turnbull, C., Boomsma, A., Milte, R., et al.[2023]

The newly developed eight-channel stimulation system for lower extremities allows for easy handling and adaptability for various functional electrical stimulation (FES) applications, enhancing its usability in rehabilitation settings.

Initial tests with paraplegic patients indicated that the system improved the smoothness of movements during stepping, demonstrating its potential effectiveness in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Vienna functional electrical stimulation system for restoration of walking functions in spastic paraplegia. Bijak, M., Mayr, W., Rakos, M., et al.[2019]

A study involving 180 poststroke patients found that combining functional electrical stimulation (FES) with body weight-supported treadmill training (BWSTT) significantly improved gait, balance, and lower limb function compared to BWSTT alone.

The FES plus BWSTT group showed enhanced nerve conduction and evoked potential responses, indicating a positive effect on neural recovery, with no adverse events reported during the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of functional electrical stimulation plus body weight-supported treadmill training for gait rehabilitation in patients with poststroke: a retrospective case-matched study. Bao, X., Luo, JN., Shao, YC., et al.[2020]

The infrared-sensing adaptive feedback control running wheel (IAFCRW) provides a safe and effective rehabilitation environment for stroke-affected rats, allowing them to exercise without the risk of falling, tailored to their individual physical capabilities.

In a study using an ischemic stroke model, the IAFCRW platform significantly reduced neurobehavioral deficits compared to traditional rehabilitation methods like treadmills and conventional running wheels, demonstrating its superior efficacy over a 3-week rehabilitation program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An adaptive fall-free rehabilitation mechanism for ischemic stroke rat patients. Chen, CC., Chang, CP., Yang, CL.[2020]

In a study involving 22 chronic stroke patients, a brain-computer interface (BCI) that used precise timing to couple brain signals with nerve stimulation led to significant improvements in motor function, including increased motor evoked potentials and better scores on the Fugl-Meyer assessment.

The results suggest that the effectiveness of BCI training relies heavily on the timing of the brain command and the afferent signal, highlighting the importance of this coupling for achieving meaningful clinical improvements in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficient neuroplasticity induction in chronic stroke patients by an associative brain-computer interface. Mrachacz-Kersting, N., Jiang, N., Stevenson, AJ., et al.[2022]

In a study involving 14 hemiplegic patients recovering from stroke or head injury, short, intensive multichannel electrical stimulation therapy helped all participants achieve independent ambulation with a crutch after an average of 14 sessions.

The therapy involved stimulating multiple muscle groups using a portable device, which allowed for detailed analysis of gait parameters, indicating its potential effectiveness in improving walking ability in hemiplegic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of gait with multichannel electrical stimulation. Malezic, M., Bogataj, U., Gros, N., et al.[2022]

The use of an electromechanical gait trainer combined with functional electrical stimulation (FES) in a 4-week program led to significant improvements in gait performance and functional activities for two patients with acute ischemic stroke.

Both patients maintained their improvements in various measures of mobility and balance, such as the Barthel Index and Berg Balance Scale, even 6 months after the intervention, indicating long-term benefits of this rehabilitation approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait training of patients after stroke using an electromechanical gait trainer combined with simultaneous functional electrical stimulation. Tong, RK., Ng, MF., Li, LS., et al.[2016]

The study introduces the first EEG-based brain-computer interface (BCI) combined with functional electrical stimulation (FES) for enabling overground walking in a person with paraplegia due to spinal cord injury (SCI).

The participant successfully operated the BCI-FES system in real time, suggesting that this innovative approach could potentially restore walking abilities in a larger population of individuals with SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain-computer interface driven functional electrical stimulation system for overground walking in spinal cord injury participant. King, CE., Wang, PT., McCrimmon, CM., et al.[2021]

In a study involving 10 stroke patients, those using brain-computer interface-based functional electrical stimulation (BCI-FES) showed significant improvements in brain activation compared to those using standard functional electrical stimulation (FES).

The BCI-FES group exhibited notable changes in attention and activation indexes in specific brain regions, indicating that this method may enhance rehabilitation outcomes more effectively than traditional FES alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of brain-computer interface-based functional electrical stimulation on brain activation in stroke patients: a pilot randomized controlled trial. Chung, E., Kim, JH., Park, DS., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-stroke-10-2022-18743

Stimulator Implant for Stroke Recovery This trial is testing a small implanted device that helps stroke survivors walk better by sending electrical signals to their muscles.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8709378/

The Effect of Implanted Functional Electrical Stimulation on ... The emerging literature suggests that implantable functional electrical stimulation may improve gait performance in stroke survivors.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1052305725000588

Effect of electrical stimulation in the treatment on patients ... The results of the meta-analysis showed that ES can significantly improve the ROM of ankle dorsiflexion and the FMA-LE scores in patients with FD after stroke.

4. neurology.org neurology.org/doi/10.1212/WNL.0000000000210429

Efficacy of Functional Electrical Stimulation for Limb ... Recent studies indicate that functional electrical stimulation (FES) applied to lower limb nerves is effective for foot drop due to stroke.

5. researchgate.net researchgate.net/publication/345656512_2188_Implanted_multijoint_functional_electrical_stimulation_assistance_improves_walking_efficiency_after_stroke_A_case_report

2188: Implanted multijoint functional electrical stimulation ... DISCUSSION/SIGNIFICANCE OF IMPACT: These preliminary data suggest improvements in walking speed with FES are accompanied by increased energy ...

6. mdpi.com mdpi.com/2077-0383/12/7/2638

Effect of Functional Electrical Stimulation in Convalescent ... In Japanese post-stroke patients with foot drop, FES did not significantly improve the 6 min walk distance during the convalescent phase.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8984173/

Therapeutic Effects of Functional Electrical Stimulation on ... Functional electrical stimulation (FES) has been used to improve physical performance in individuals with neurological disorders and increase ...

8. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.118.021359

New Directions in Treatments Targeting Stroke Recovery A recent randomized human clinical trial of vagal nerve stimulation paired with rehabilitation demonstrated safety and feasibility, and efficacy ...