An Early Feasibility Study of the ReHAB System

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Jennifer Sweet, MD
Study ID
NCT03898804
Status
Recruiting
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Conditions

  • Tetraplegia

Eligibility Criteria

Sex
ALL
Age
22 Years - 65 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Apr 9, 2019
Status verified
Jul 2025
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: BCI and FES
    Surgical implantation of the device and testing for 13 months with an optional 5 year extension study.

Primary Outcome Measure

Incidence of treatment-related adverse events [ Time Frame: 13 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical CenterClevelandOhio44106
Jennifer Sweet, MD
[email protected]
216-844-8522
Mario Becerra, RN
[email protected]
216-844-1734
Jennifer Sweet, MD (PRINCIPAL_INVESTIGATOR)
Bolu Ajiboye, PhD (SUB_INVESTIGATOR)

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By research site
University Hospitals Cleveland Medical Center· Cleveland, OH

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