Brain Computer Interface for Spinal Cord Injury

Overseen By Emily Graczyk, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Disqualifiers: Lack of ReHAB system function, severe pain, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how certain types of nerve stimulation can help restore sensation for people with spinal cord injuries. Participants will receive small electrical pulses to the brain and arm nerves to understand how these signals affect sensation. Researchers will test different patterns of stimulation to determine which ones improve feeling and how combining both methods might work. This trial is for those who have already participated in a previous study called "ReHAB" and had specific components implanted.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatments for spinal cord injuries.

Do I need to stop my current medications for this 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 this brain computer interface is safe for spinal cord injury patients?

Research has shown that intracortical microstimulation (ICMS) has been safely used in humans for over ten years, reliably creating sensations in people with spinal cord injuries. Studies indicate that ICMS can restore a sense of touch, which is crucial for those using advanced prosthetic devices. No major safety issues have been reported with ICMS, making it a well-tolerated option.

For peripheral nerve stimulation (PNS), research has found it safe when used at specific levels. Long-term PNS at low frequencies is considered safe and effective. It has been successfully used for pain relief during surgeries, demonstrating that it is generally well-tolerated.

Overall, both ICMS and PNS have a strong safety record and show promise in helping people with spinal cord injuries regain sensation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these neurostimulation methods because they offer a novel approach to improving sensory function in individuals with tetraplegia, a condition where traditional treatments often focus on physical rehabilitation and assistive devices. Intracortical Microstimulation (ICMS) directly stimulates the brain's sensory cortex, which could restore sensation by tapping into the brain's natural pathways. Peripheral Nerve Stimulation (PNS) targets the nerves in the arms, potentially enhancing sensory feedback by using specially implanted electrodes. By combining these techniques, there's hope for a more integrated sensory experience, which could significantly improve quality of life for those affected by spinal cord injuries.

What evidence suggests that intracortical microstimulation and peripheral nerve stimulation could be effective for spinal cord injury?

Research has shown that intracortical microstimulation (ICMS), one of the treatments studied in this trial, can help people with spinal cord injuries regain a sense of touch. Studies have found that ICMS enhances the ability to feel touch and detect vibrations on the skin, allowing people to experience sensations they couldn't before.

Similarly, peripheral nerve stimulation (PNS), another treatment option in this trial, has demonstrated effectiveness in pain relief and recovery improvement for these patients. Many individuals experience significant long-term pain relief, with about two-thirds reporting at least 50% ongoing relief from nerve pain. These findings suggest that both ICMS and PNS could be promising options for restoring sensation and managing pain in individuals with spinal cord injuries. ^{1 2 6 7 8}

Who Is on the Research Team?

Emily Graczyk, Ph.D.

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

This trial is for individuals who have a spinal cord injury and are already part of the 'ReHAB' study, with implanted electrodes in their brain and arm nerves. They must be able to follow the study protocol but cannot participate if their ReHAB system isn't working or they have severe pain/chronic conditions that interfere with study activities.

Inclusion Criteria

I am part of the ReHAB trial and have had the ReHAB device implanted.

I am willing and able to follow the study rules.

Exclusion Criteria

Lack of function or operability of all implanted ReHAB system components

I do not have severe pain or a chronic condition that stops me from participating in study activities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intracortical microstimulation (ICMS) and peripheral nerve stimulation (PNS) to study the perception and functional impact of sensory neurostimulation.

24 months

Regular visits for stimulation sessions and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intracortical Microstimulation (ICMS)
• Peripheral Nerve Stimulation (PNS)

Trial Overview The trial tests how electrical stimulation via Brain Computer Interface (BCI) - Functional Electrical Stimulation (FES) system can restore sensation in tetraplegia patients. It involves Intracortical Microstimulation (ICMS) for brain sensations and Peripheral Nerve Stimulation (PNS) for arm nerve sensations, alone or combined.

How Is the Trial Designed?

Group I: Intracortical microstimulation and peripheral nerve stimulation for people with tetraplegia Experimental Treatment 1 Intervention

The purpose of the proposed study is to investigate the perception and functional impact of sensory neurostimulation in participants with tetraplegia. Investigators will develop and implement novel paradigms of intracortical microstimulation (ICMS) applied to primary somatosensory cortex (S1) and peripheral nerve stimulation (PNS) applied to upper extremity nerves through chronically-implanted cuff electrodes. Investigators will also develop and assess hybrid neurostimulation paradigms involving paired application of ICMS and PNS. For each paradigm, investigators will quantify the perceived sensation with classic psychophysical methods. Investigators will also implement the approach into closed-loop tasks in virtual reality controlled through decoded cortical signals recorded from intracortical microelectrode arrays. Finally, investigators will assess the impact of each stimulation paradigm on residual sensory function.

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

University Hospitals Cleveland Medical Center

Collaborator

Trials

348

Recruited

394,000+

Cleveland Clinic Lerner Research Institute

Collaborator

Trials

1

Recruited

20+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40832410/

Intracortical microstimulation in humans: a decade of safety ... Background: Intracortical microstimulation (ICMS) of somatosensory cortex can restore a sense of touch to people with spinal cord injury (SCI).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07225582?rank=5

Development of Optimal Sensory Feedback Strategies to ... The goal of the ReHAB clinical trial is to restore arm and hand movement and sensation in individuals with paralysis from a spinal cord injury.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07225582

Development of Optimal Sensory Feedback Strategies to ... The goal of the ReHAB clinical trial is to restore arm and hand movement and sensation in individuals with paralysis from a spinal cord injury.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12363726/

Intracortical microstimulation in humans: a decade of safety ... Intracortical microstimulation (ICMS) of somatosensory cortex can restore a sense of touch to people with spinal cord injury (SCI).

5. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X25000786

Subthreshold intracortical microstimulation of human ... We found that subthreshold ICMS enhanced sensitivity to touch on the skin, as evidenced by a reduction in vibrotactile detection thresholds.

6. medrxiv.org medrxiv.org/content/10.1101/2025.08.11.25332271v1.full.pdf

Intracortical microstimulation in humans: a decade of safety ... Background. Intracortical microstimulation (ICMS) of somatosensory cortex can restore a sense of touch to people with spinal cord injury (SCI).

7. neurology.org neurology.org/doi/10.1212/WNL.0000000000013173

Intracortical Somatosensory Stimulation to Elicit Fingertip ... These results suggest that ICMS can enable the delivery of consistent and localized fingertip sensations during object manipulation by neuroprostheses.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0142961225006519

Intracortical Microstimulation Induces Rapid Microglia ... Spinal cord stimulation for treating chronic pain also resulted in reduced microglia activation compared to unstimulated controls. These results ...