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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 Jonathan Miller, 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
Onset of tetraplegia at least 12 months prior to enrollment, with stability of weakness for at least 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 months
Awards & highlights

ReHAB Trial 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.Check my eligibility
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.See study design
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.

ReHAB Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check β€œYes” for the criteria below
Select...
I have tetraplegia from a spinal cord injury or stroke, affecting my arms' function.
Select...
I have had paralysis in all four limbs for over a year with stable condition for the last 3 months.
Select...
I am between 22 and 65 years old.
Select...
My scalp is healthy and free of any sores or lesions.
Select...
I can communicate clearly or have a reliable way to say yes or no.

ReHAB Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment-related adverse events
Secondary outcome measures
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.

ReHAB 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.

Find a Location

Who is running the clinical trial?

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)

Media Library

BCI and FES (Brain-Computer Interface and Functional Electrical Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03898804 β€” N/A
Quadriplegia Research Study Groups: BCI and FES
Quadriplegia Clinical Trial 2023: BCI and FES Highlights & Side Effects. Trial Name: NCT03898804 β€” N/A
BCI and FES (Brain-Computer Interface and Functional Electrical Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03898804 β€” N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the participant demographic of this study inclusive of octogenarians?

"As per the eligibility criteria of this clinical trial, people aged between 22 and 65 are eligible to apply."

Answered by AI

Who is eligible to partake in this experiment?

"This clinical investigation is currently recruiting 12 individuals aged between 22 and 65 who have tetraplegia. Essential criteria for enrollment include: At least one year of stable paralysis, the ability to communicate using understandable speech or a reliable yes/no system, availability in their geographic area for at least 13 months after recruitment along with compliance to evaluation schedules, diagnosis of static tetraplegia due to stroke or spinal cord injury that impedes upper body motor activity, intact cortical structures that can maintain BCI control tasks for up to 1 year., life expectancy exceeding 13 months, access within a three-hour drive from study site (or temporary relocation"

Answered by AI

What is the maximum number of participants taking part in this clinical trial?

"Affirmative. Clinicaltrials.gov details that recruitment for this trial, initially posted on April 9th 2019, is still ongoing and 12 volunteers are being sought from a single site."

Answered by AI

Are there any openings in this medical study for prospective participants?

"Per the clinicaltrials.gov website, this medical trial is currently open to recruits. The initial posting of the study was on April 9th 2019 and it has been amended as recently as May 14th 2022."

Answered by AI
~2 spots leftby Mar 2025