NCT03680872

Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (estimated)
• Sponsor: Chad Bouton · Academic / Other
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a single-cohort early feasibility trial to determine whether an investigational device called the Bidirectional Neural Bypass System can lead to the restoration of movement and sensation in the hand and wrist of up to seven individuals with tetraplegia.

Detailed description

This study consists of the following three phases: baseline visit, surgical procedure, and restoration sessions. At the baseline visit, participants will undergo a medical history review, physical and neurological examination, functional assessment of motor and sensory capabilities, a functional magnetic resonance image (fMRI), diffusion tensor image (DTI), and a transcutaneous neuromuscular and transcutaneous spinal cord stimulation test. Participants deemed eligible for continued participation will then undergo a craniotomy under anesthetic sedation to implant the investigational device. The surgeon will implant microelectrode arrays into the primary motor cortex to record neural activity associated with desired movements and into the primary somatosensory cortex to deliver stimulation in order to provide sensory perception. While in surgical recovery, participants will have their vital signs monitored, be provided pain medication and antibiotics, and undergo a computed tomography (CT). The participants may also undergo electromyography and microneurography while in recovery. After being evaluated by a physician, the participants will be discharged from the hospital to continue their recovery. After fully recovering, participants will attend restoration sessions at the Feinstein Institute for Medical Research's Center for Bioelectronic Medicine. Participants will attend up to 3 study sessions a week for approximately 48 months, with each session lasting up to 4 hours. The sessions will progressively focus on identifying neural activity related to desired movements, restoring volitional control of the hand and wrist, restoring tactile perception, and then restoring volitional control and tactile perception of the hand and wrist simultaneously. During the sessions, participants will have brain signals recorded from electrodes implanted in the brain, receive transcutaneous electrical stimulation to the arm and/or spinal cord, and receive a small amount of electrical current to the electrodes implanted in the brain. The participants may also undergo electromyography and microneurography during some of the sessions. The study will be considered complete after completion of enrollment (up to 7 participants), completion of study procedures by all participants, and the completion of analysis of identifiable study data.

Conditions

• Spinal Cord Injuries
• Spinal Cord Injury Cervical

Interventions

Type	Name	Description
DEVICE	Bidirectional Neural Bypass System	These participants will receive the investigational device called the Bidirectional Neural Bypass System. The study intends to use this device to restore volitional movement and sensation to the hand and wrist of an individual during its use in the laboratory.

Timeline

• Start date: 2019-09-30
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2018-09-21
• Last updated: 2026-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study