An interventional study of Bidirectional Neural Bypass System in Spinal Cord Injuries and Spinal Cord Injury Cervical, sponsored by Chad Bouton. Recruiting at 1 site in United States. Open to participants aged 22 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by Chad Bouton · Not applicable, Interventional, and Treatment
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.
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.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 7 is below the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →This is the only study on the registry with Chad Bouton as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Individuals having or exhibiting any of the following:
Individuals with any of the following co-morbid conditions that would interfere with study activities or response to treatment:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group consists of individuals with tetraplegia receiving an investigational device called the Bidirectional Neural Bypass System.
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.
Restoration of Movement
The primary outcome of restoring movement will be evaluated through Graded Redefined Assessment of Strength, Sensibility \& Prehension. The performance will be graded on a numeric scale from 0-92, where a higher number indicates a better outcome. Participants will complete 10 distinct arm, wrist, and finger movements. The movements will be evaluated on a 5-point scale ranging from no movement to normal movement for a total of 0-50. Participants will be asked to perform a cylindrical grasp, key pinch, and a thumb-index pinch. The movements will be evaluated on a 4-point scale ranging from an inability to position wrist and fingers to able to perform movement with normal force for a total of 0-12. Participants will be asked to pour water, unscrew lids, place pegs on a board, open a lock, drop coins in a slot, and screw nuts. The movements will be evaluated on a 5-point scale ranging from 0% completed to 100% completed with expected grasp and no difficulties for a total of 0-30.
Time frame: The primary outcome will be assessed over the course of 48 months during the study's restoration sessions.
Restoration of Sensation
The primary outcome of restoring the perception of tactile sensation of the hand will be evaluated through the 5-Point Likert Scale. Participants will be asked whether they perceive sensation in response to objects being placed against the hand and fingertips. Participants will indicate whether they feel the object by selecting either strongly disagree (1), disagree (2), neutral (3), agree (4), or strongly agree (5). A higher total response score indicates an improvement in outcome.
Time frame: The primary outcome will be assessed over the course of 48 months during the study's restoration sessions.
Plan to share: No — Currently, there are no plans to make individual participant data available.
Started Sep 2019 (actual). Primary completion is estimated for Dec 2027, 99 months after the start.
Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 99 months is above that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
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