What side effects are associated with this type of intervention?

Common treatments for hemiplegia, particularly those involving electrical stimulation such as implanted stimulators, can have several side effects. These may include skin irritation or discomfort at the site of electrode placement, muscle soreness, and in some cases, pain during stimulation. There is also a risk of infection at the implantation site, hardware malfunction, and in rare cases, nerve damage. Additionally, patients may experience headaches, dizziness, or fatigue following stimulation sessions. It is important for patients to discuss these potential side effects with their healthcare provider to weigh the benefits and risks of such treatments.

What prior FDA approvals exist?

There is limited specific information on FDA-approved treatments for hemiplegia involving electrical stimulation. However, electrical stimulation has shown modest benefits in stroke patients, which could be relevant for hemiplegia treatment. Devices like spinal cord stimulators and other neuromodulation techniques are being explored for their potential to improve motor function in neurological conditions, including post-stroke rehabilitation. Further high-quality research is needed to establish their efficacy and safety for routine clinical use.

What other types of research exist?

Promising, novel alternatives to implanted stimulators for hemiplegia patients include: 1) Transcutaneous supraorbital nerve stimulation, which has shown efficacy in reducing pain intensity in migraine patients and may have potential applications in motor function improvement. 2) Remote electrical neuromodulation, which uses a non-invasive armband device controlled by a smartphone to reduce pain and could be adapted for motor function enhancement. Both methods are non-invasive and have demonstrated positive outcomes in clinical trials.

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Neurostimulation Device

Stimulator Implant for Stroke Recovery

N/A

Recruiting

Led By Nathan Makowski, PhD

Research Sponsored by MetroHealth Medical Center

Eligibility Criteria Checklist

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

Must have

Able to ambulate, but does not require the assistance of more than one person

Innervated and excitable lower extremity and trunk musculature

Must not have

Complications of stroke that result in an increased risk of falls (apraxia, uncompensated hemineglect, hemianopsia etc.)

Acute orthopedic problems (severe scoliosis, joint dislocations, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, ~18 weeks post implant, ~44-week post implant

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a small implanted device that helps stroke survivors walk better by sending electrical signals to their muscles. The device is surgically placed and helps the muscles contract, making it easier to walk. This method has been shown to improve walking ability in stroke patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, typical risks may include discomfort at the implant site, potential infection risk from surgery or hardware malfunction leading to abnormal sensations or movements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My leg and lower back muscles respond normally to stimulation.

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I have limited movement in my hip, knee, or ankle when walking.

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My muscle stiffness in certain joints is mild to moderate.

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I walk slower than a certain speed during a short test.

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My leg movement is severely limited.

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I am between 21 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have severe difficulties in thinking and communicating.

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I do not have major health issues like heart problems, severe skin conditions, uncontrolled seizures, or serious issues with my immune system, lungs, kidneys, or circulation.

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I have heart or lung disease.

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I often fall down.

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My diabetes or blood pressure is not well-managed.

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I have had fractures without injury or have very low bone density.

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I have trouble moving my hips fully.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, ~18 weeks post implant, ~44 week post implant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, ~18 weeks post implant, ~44 week post implant

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, ~18 weeks post implant, ~44 week post implant for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Difference in Gait speed

Secondary study objectives

Difference in Usability Rating Scale (URS)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Implantation, controller development, and evaluationExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IRS-8

1996

N/A

~20

0 / 16Eligibility criteria met

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

Electrical stimulation therapies for Hemiplegia involve sending electrical impulses to muscles or nerves to improve motor function. These impulses can enhance muscle strength, reduce spasticity, and promote neuroplasticity, which is the brain's ability to reorganize itself by forming new neural connections. This is crucial for Hemiplegia patients as it can lead to better mobility and functional independence, significantly improving their ability to perform daily activities and enhancing their overall quality of life.

Noninvasive Brain Stimulation Therapies to Promote Recovery of Consciousness: Where We Are and Where We Should Go.Electrical Stimulation of Injected Muscles to Boost Botulinum Toxin Effect on Spasticity: Rationale, Systematic Review and State of the Art.The ineffective role of cathodal tDCS in enhancing the functional motor outcomes in early phase of stroke rehabilitation: an experimental trial.