NCT03898804

An Early Feasibility Study of the ReHAB System

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Jennifer Sweet, MD · Academic / Other
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The overall purpose of this trial is to advance development of a novel technological approach to allow individuals with tetraplegia to interact with their environment using their own paralyzed limbs by combining recording of brain activity, brain stimulation to provide sensory feedback, and stimulation of the paralyzed extremities based on neural recordings. Device Name: Reconnecting the Hand and Arm to the Brain (ReHAB) System Intended Use The proposed device is intended to allow greater functional independence for individuals who are paralyzed due to disease or injury. The purpose of this trial is to advance development of a novel technological approach to allow individuals with tetraplegia to interact with their environment using their own paralyzed limbs by combining recording of brain activity, brain stimulation to provide sensory feedback, and stimulation of the paralyzed extremities based on neural recordings. The target population are individuals with high tetraplegia, defined as less than antigravity weakness of both upper extremities and both lower extremities as a result of an identified and static (stable for at least 3 months) injury or disease affecting upper motor neurons process that prevents motor neural activity from activating muscles below the neck to perform functional activities. Injuries and diseases that lead to this clinical condition include spinal cord injury, and stroke. Objective(s): The primary objective of this study is to evaluate the safety, tolerability, and potential efficacy of an approach combining multiple intracortical brain recording/stimulating microarrays with direct peripheral nerve and muscle stimulation for restoration of arm and hand movement in people with high tetraplegia. Secondary objectives include validation of the combined platform described above as a clinical device to allow paralyzed individuals to have a more meaningful interaction with their environment as assessed by ability to perform brain-controlled reaching and grasping tasks that ultimately might allow for greater functional independence.

Conditions

• Tetraplegia

Interventions

Type	Name	Description
DEVICE	BCI and FES	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.

Timeline

• Start date: 2019-04-09
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2019-04-02
• Last updated: 2025-07-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study