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BCI-FES System for Quadriplegia (ReHAB Trial)
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.
ReHAB Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check βYesβ for the criteria belowReHAB Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ReHAB Trial Design
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Who is running the clinical trial?
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- You drink more than one alcoholic drink per day.I currently have an infection or unexplained fever.I do not have any serious health issues that would prevent me from undergoing surgery or participating in tests.I have tetraplegia from a spinal cord injury or stroke, affecting my arms' function.You have a weakened immune system.I have had paralysis in all four limbs for over a year with stable condition for the last 3 months.I need ongoing treatments like diathermy or ultrasound.I am between 22 and 65 years old.I regularly take medications that could slow down my thinking or movement.I have had a heart attack or irregular heartbeats.I have had a seizure in the last 3 months.You need to have healthy brain structures and a stable health outlook to be able to do the brain-computer interface tasks for at least one year.I've had a severe autonomic reaction needing urgent medication in the last 3 months.You have a condition called hydrocephalus that needs surgery to drain fluid from your brain.I cannot undergo CT scans due to health reasons.I regularly use steroids or immunosuppressant drugs.You have a device like a pacemaker or spinal cord stimulator implanted in your body.I have severe stiffness or joint issues in my arms that limit my movement.You have tried to hurt yourself on purpose in the past year before joining the study.You are expected to live for more than 13 months.You must be able to live within a three-hour drive of the study site or be able to move there temporarily during the study.I am pregnant, breastfeeding, or not using birth control while of childbearing age.My scalp is healthy and free of any sores or lesions.I have diabetes that is not well-controlled with insulin.You have a reliable support system for your emotional and mental well-being.You have a medical condition that needs regular MRI scans, or you can't have an MRI due to health reasons.I regularly use blood thinners, but can stop them temporarily for surgery.I rely on a ventilator full-time.I can communicate clearly or have a reliable way to say yes or no.I haven't had active cancer in the last year, except for certain skin cancers.I have had infections in my bones or skin conditions affecting my scalp.
- Group 1: BCI and FES
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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"
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."
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."
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