An Early Feasibility Study of the ReHAB System

NCT03898804 | Recruiting DMC FDA Device

• 1 other identifier: STUDY20190226
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to examine the feasibility of a system that involves implanting small electrodes in the parts of the brain that control movement and sensation, and combining that with electrodes in the upper arm and shoulder to activate paralyzed muscles of the arm and hand. This system is intended for people with extensive paralysis in their arms. The small electrodes in the brain will be used to attempt to measure intended movements, and the muscles in the arm and hand will be stimulated to attempt to follow those intentions. The study is a prospective, non-randomized, open-label, exploratory safety/feasibility trial of up to 12 subjects. The Primary Endpoint will be evaluation over the first 13 months after implantation, after which the subjects will have the option of removal of the device or continued participation in a long-term study.

Conditions

Tetraplegia

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-related adverse events

  Successful implantation of brain and extremity recording/stimulating electrodes for 1 year without explantation or device-related serious adverse events.

  13 months

Secondary Outcomes (3)

• 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.

  13 months

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

  13 months

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

  13 months

Study Arms (1)

BCI and FES

EXPERIMENTAL

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

Device: BCI and FES

Interventions

BCI and FES DEVICE

The intervention consists of surgical implantation of the device components, BCI and FES that will interface with computers that process and decode neural information, compute stimulation parameters, and control communication between the device components. The device will be tested during research sessions spanning a 13-month period.

BCI and FES

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 22 and 65 years of age.
• 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.
• Must have sufficiently intact cortical motor structures and stable medical prognoses to be able to perform the BCI control tasks for at least one year. .
• Ability to speak understandably or, if unable to speak understandably, a reliable means of yes/no communication.
• Life expectancy greater than 13 months.
• Chronic care environment within a three-hour drive of the study site or the ability to temporarily relocate to a residence within a three-hour drive of the study site.
• Willingness to remain available (geographically stable) for at least 13 months after enrollment, including maintenance of the evaluation schedule, frequent visits to the Investigator's office, and visits of Sponsor personnel to the subject's chronic care environment.
• Willingness to allow videotape recordings to be made of the surgical procedure (for training purposes) and portions of the Feasibility Evaluations.
• A stable psychosocial support system.
• Scalp devoid of any lesions or skin breakdown precluding surgery.
• Ability to provide voluntarily informed consent in accordance with Site institutional policies and willingness to release of Personal Health Information from the date of the injury or disease onset through the completion of the clinical Study.
• Availability of caregivers capable of providing the necessary daily care of the subject's skin and electrode externalization sites.

You may not qualify if:

• Presence of an implanted stimulator such as a pacemaker, spinal cord stimulator, cochlear implant, deep brain stimulator, vagus nerve stimulator, or defibrillator. (Implanted intrathecal pumps for pain or spasticity, cough implants, or diaphragmatic pacers are not excluded.)
• Any active infection(s) or unexplained fever.
• Active cancer within the one year prior to enrollment (other than adequately treated basal or squamous cell skin cancer).
• Uncontrolled insulin-dependent diabetes mellitus.
• Hydrocephalus requiring diversion of cerebrospinal fluid.
• Autonomic dysreflexia within three months prior to enrollment that required urgent evaluation and pharmacologic intervention prescribed by a physician.
• Seizure within 3 months prior to enrollment.
• Any medical condition expected to require routine MRI imaging or subjects with contraindication(s) to MRI.
• History of osteomyelitis or skin disorder that causes excessive skin sloughing, lesions or breakdown of the scalp.
• Chronic use of medications such as sedatives that may significantly retard motor coordination and cognitive ability.
• Chronic use of anticoagulant medications. (Subjects receiving prophylactic anticoagulation solely for the prevention of deep venous thrombosis are not excluded, but must be able to have their prophylactic anticoagulation suspended temporarily for the surgical procedure and immediate post-operative period.)
• Chronic use of steroids or immunosuppressant therapy.
• 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.
• Pregnant, lactating, or of childbearing age and not using adequate birth control.
• Active consumption of more than 1 alcoholic beverage per day.

Sponsors & Collaborators

• Jennifer Sweet, MD: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Related Publications (3)

• Gardner J. Savings for states? Senate budget aims to reinstate Medicaid cost sharing. Mod Healthc. 1997 Jul 14;27(28):66. No abstract available.

  PMID: 10168522 BACKGROUND

• Jakes RS, Alexander BJ, Marcu V, Ajiboye AB, Tyler DJ. A methodological framework for the efficient characterization of peripheral nerve stimulation parameters. J Neural Eng. 2025 Oct 27;22(5):056041. doi: 10.1088/1741-2552/ae0d31.

  PMID: 41022103 DERIVED

• Jakes RS, Alexander BJ, Marcu VI, Ajiboye AB, Tyler DJ. A Methodological Framework for the Efficient Characterization of Peripheral Nerve Stimulation Parameters. medRxiv [Preprint]. 2025 May 23:2025.03.29.25324704. doi: 10.1101/2025.03.29.25324704.

  PMID: 40661284 DERIVED

Related Links

• This website provides information about the ReHAB Study.

MeSH Terms

Conditions

Quadriplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Sweet, M.D.

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Sweet, M.D.

CONTACT

(216) 844-8522; jennifer.sweet@uhhospitals.org

Mario Beccera, RN

CONTACT

2168441734; Mario.Becerra@UHhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician

Model Details: The study is a prospective, non-randomized, open-label, exploratory safety/feasibility trial of up to 12 subjects. The Primary Endpoint will be evaluation over the first 13 months after implantation, after which the subjects will have the option of removal of the device or continued participation in a long-term study for an additional 5 years, for a total of up to 73 months.

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: April 2, 2019
• Study Start: April 9, 2019
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)