Actively Recruiting

Phase Not Applicable
Age: 22Years - 65Years
All Genders
ID03898804

An Early Feasibility Study to Assess the Effects of the Reconnecting the Hand and Arm to the Brain (ReHAB) System

Led by Jennifer Sweet, MD · Updated on 2025-07-16

12

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a novel system designed to help people with severe arm paralysis, known as tetraplegia, caused by diseases or injuries like spinal cord injury or stroke. This system combines small electrodes implanted in the brain areas controlling movement and sensation with electrodes on the upper arm and shoulder to stimulate paralyzed muscles. The goal is to measure intended movements through brain signals and stimulate muscles accordingly to restore arm and hand function. This is an open-label, exploratory safety and feasibility study enrolling up to 12 participants. The study involves surgical implantation of the Reconnecting the Hand and Arm to the Brain (ReHAB) System, which includes brain-computer interface (BCI) and functional electrical stimulation (FES) components. After implantation, participants will undergo research sessions over 13 months to test and adjust the device. Following this period, participants can choose to remove the device or continue in a long-term extension study lasting up to 5 years. Participants will be closely monitored through frequent visits and evaluations during the 13-month testing phase. Researchers will assess safety by tracking treatment-related adverse events and measure functional improvements using tasks such as brain-controlled cursor movement, activities of daily living tests, and grasp-release tasks. Participants must be available for ongoing follow-up and may allow video recordings of procedures and evaluations. The trial aims to determine the safety, tolerability, and potential effectiveness of this combined brain and muscle stimulation approach for restoring arm and hand movement.

CONDITIONS

Brief Title

An Early Feasibility Study of the ReHAB System

Who Can Participate

Age: 22Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 22 and 65 years
  • Tetraplegia caused by a stable spinal cord injury or stroke preventing upper extremity function
  • Onset of tetraplegia at least 12 months before enrollment with weakness stable for at least 3 months
  • Intact cortical motor structures and stable medical condition to perform brain control tasks for at least one year
  • Ability to communicate understandably or via reliable yes/no method
  • Life expectancy greater than 13 months
  • Access to chronic care within 3 hours of study site or willingness to relocate temporarily
  • Willingness to remain geographically stable and available for at least 13 months including frequent visits
  • Consent to videotaping of surgery and evaluations
  • Stable psychosocial support system
  • Scalp free of lesions or skin breakdown preventing surgery
  • Ability to provide informed consent and release personal health information
  • Availability of caregivers for daily skin and electrode care
Not Eligible

You will not qualify if you...

  • Presence of implanted stimulators like pacemaker, spinal cord stimulator, cochlear implant, deep brain stimulator, vagus nerve stimulator, or defibrillator
  • Active infections or unexplained fever
  • Active cancer within one year prior except treated skin cancer
  • Uncontrolled insulin-dependent diabetes mellitus
  • Hydrocephalus requiring cerebrospinal fluid diversion
  • Autonomic dysreflexia within 3 months requiring urgent treatment
  • Seizure within 3 months prior to enrollment
  • Medical conditions requiring routine MRI or contraindications to MRI
  • History of osteomyelitis or scalp disorders causing skin breakdown
  • Chronic use of sedatives impairing coordination or cognition
  • Chronic use of anticoagulants unless temporarily suspendable
  • Chronic steroid or immunosuppressant therapy
  • Active treatment for serious medical, neurological, or psychiatric conditions affecting surgery or participation
  • Pregnancy, lactation, or childbearing age without adequate birth control
  • Active consumption of more than one alcoholic beverage per day
  • Suicide attempt within 12 months prior
  • History of myocardial infarction or unstable cardiac arrhythmia
  • Participation in other investigational studies interfering with this study
  • Immunocompromised status
  • Need for ongoing diathermy or ultrasound treatments
  • Severe upper extremity joint contractures or high spasticity limiting movement
  • Contraindications to CT
  • Ventilator dependency (except occasional assisted ventilation during sleep)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery plus immediate recovery period

Participants undergo surgical implantation of the ReHAB System components including brain-computer interfaces and functional electrical stimulation devices.

1 surgical visit followed by several immediate post-operative visits

Implementation

Duration - 13 months

Participants engage in testing and use of the ReHAB System over a 13-month period to assess device safety, tolerability, and efficacy in restoring arm and hand movement.

Frequent research sessions during the 13-month testing period

Trial Site Locations

Total: 1 location

1

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

Loading map...

Research Team

J

Jennifer Sweet, M.D.

M

Mario Beccera, RN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

Similar Trials

A Neuroprosthesis for Seated Posture and Balance

Spinal Cord Injury

Actively Recruiting

1 location

Brain Controlled Spinal Cord Stimulation in Participants Wit...

Cervical Spinal Cord Injury

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Reconnecting the Hand and Arm to the Brain: Efficacy of Neural Interfaces for Sensorimotor Restoration after Tetraplegia.

Eric Z Herring, Emily L Graczyk, William D Memberg...

https://pubmed.ncbi.nlm.nih.gov/37162904