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Brain-Computer Interface and Functional Electrical Stimulation

BCI-FES System for Quadriplegia (ReHAB Trial)

N/A

Recruiting

Led By Jonathan Miller

Research Sponsored by Jennifer Sweet, MD

Eligibility Criteria Checklist

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

Must have

Tetraplegia due to a static identified disease process (spinal cord injury or stroke) that prevents functional activity of the upper extremity

Age between 22 and 65 years of age

Must not have

Any active infection(s) or unexplained fever

Active treatment for another serious medical, neurological or psychiatric disease or disorder that could seriously affect the subject's ability to undergo surgical implantation of the electrodes or participate in the testing sessions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 13 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is examining the feasibility of a system that would allow people with paralysis to control their arm and hand muscles. The system involves electrodes in the brain and arm that read and stimulate muscles respectively. The study will last 13 months and will evaluate safety and feasibility.

Who is the study for?

This trial is for adults aged 22-65 with stable tetraplegia from spinal cord injury or stroke, who live within a three-hour drive of the study site (or can relocate) and have a life expectancy over 13 months. Participants need intact brain motor areas, reliable communication ability, and a strong support system. They must not be pregnant, on certain medications, or have conditions that conflict with the study requirements.

What is being tested?

The ReHAB System being tested involves implanting electrodes in the brain to detect movement intentions and stimulating arm muscles to mimic these movements in people with arm paralysis. The trial will assess safety/feasibility over 13 months post-implantation with an option for long-term follow-up.

What are the potential side effects?

Potential side effects may include discomfort at electrode sites, risk of infection from surgery, possible skin irritation around scalp electrodes, and muscle fatigue due to electrical stimulation. There might also be risks associated with any surgical procedure such as bleeding or adverse reactions to anesthesia.

Eligibility Criteria

Inclusion Criteria

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

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I have tetraplegia from a spinal cord injury or stroke, affecting my arms' function.

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I am between 22 and 65 years old.

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My scalp is healthy and free of any sores or lesions.

Exclusion Criteria

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

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I currently have an infection or unexplained fever.

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I do not have any serious health issues that would prevent me from undergoing surgery or participating in tests.

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I have had a heart attack or irregular heartbeats.

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I need ongoing treatments like diathermy or ultrasound.

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I've had a severe autonomic reaction needing urgent medication in the last 3 months.

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I regularly use steroids or immunosuppressant drugs.

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I cannot undergo CT scans due to health reasons.

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I have severe stiffness or joint issues in my arms that limit my movement.

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I am pregnant, breastfeeding, or not using birth control while of childbearing age.

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I have diabetes that is not well-controlled with insulin.

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I haven't had active cancer in the last year, except for certain skin cancers.

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I have had infections in my bones or skin conditions affecting my scalp.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 13 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~13 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of treatment-related adverse events

Secondary study objectives

Change in number of objects successfully grasped and moved during a timed session, as measured by the Grasp Release Test.

Change in number of tasks performed as measured by the ADL Abilities Test.

Success rate of target acquisition of a cursor on a computer screen controlled by neural signals, using a standard center-out-center random target display.

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: BCI and FESExperimental Treatment1 Intervention

Surgical implantation of the device and testing for 13 months with an optional 5 year extension study.

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jennifer Sweet, MDLead Sponsor

Jonathan Miller, MDLead Sponsor

Jonathan MillerPrincipal Investigator - University Hospitals Cleveland Medical Center

University Hospitals Case Medical Center, University Hospitals MacDonald Women's Hospital, University Hospitals Medical Group, Inc., University Hospitals Rainbow Babies & Children's Hospital

Case Western Reserve University School Of Medicine (Medical School)

University Hosp Of Cleveland (Residency)