Health TrialsbyHealthPanel

An Early Feasibility Study of the ReHAB System

ConditionTetraplegia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-65
SponsorUniversity Hospitals Cleveland Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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. .

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: BCI and FESExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
13 months

Secondary outcomes

1

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.

The participant will control the position of a cursor on a monitor using the recorded neural signals and attempt to move the cursor to the target.

Time frame
13 months
2

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

The participant will control the stimulated movement of their arm and hand using the recorded neural signals. The participant will demonstrate the ability to perform some of the activities of daily living (ADLs) that are part of the ADL Abilities Test.

Time frame
13 months
3

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

The participant will control the stimulated movement of their arm and hand using the recorded neural signals. The participant will demonstrate the ability to grasp and move a series of objects that are part of the Grasp Release Test.

Time frame
13 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospitals Cleveland Medical Center

Lead sponsor

Source ClinicalTrials.gov
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