Bidirectional Neural Bypass System for Spinal Cord Injury
Study Summary
This trial will test whether an investigational device can help people with tetraplegia regain movement and sensation in their hand and wrist.
- Spinal Cord Injury Cervical (SCI-C)
- Spinal Cord Injury
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 0 Secondary · Reporting Duration: The primary outcome will be assessed over the course of 12 months during the study's restoration sessions.
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Spinal Cord Injury Participants
1 of 1
Experimental Treatment
3 Total Participants · 1 Treatment Group
Primary Treatment: Bidirectional Neural Bypass System · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 22 - 65 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| New York | 100.0% |
How old are they?
| < 18 | 100.0% |
What site did they apply to?
| Northwell Health's The Feinstein Institute for Medical Research | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
- Sharma, Gaurav, David A. Friedenberg, Nicholas Annetta, Bradley Glenn, Marcie Bockbrader, Connor Majstorovic, Stephanie Domas, W. Jerry Mysiw, Ali Rezai, and Chad Bouton. 2016. “Using an Artificial Neural Bypass to Restore Cortical Control of Rhythmic Movements in a Human with Quadriplegia”. Scientific Reports. Springer Science and Business Media LLC. doi:10.1038/srep33807.
- Bouton, Chad E., Ammar Shaikhouni, Nicholas V. Annetta, Marcia A. Bockbrader, David A. Friedenberg, Dylan M. Nielson, Gaurav Sharma, et al.. 2016. “Restoring Cortical Control of Functional Movement in a Human with Quadriplegia”. Nature. Springer Science and Business Media LLC. doi:10.1038/nature17435.
- Chad Bouton 2019. "Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03680872.
Frequently Asked Questions
Is this clinical trial open to participants younger than 45 years old?
"To participate in this study, qualified applicants must be between the ages of 22 and 65. Alternatively, there are 138 trials for individuals below the age of majority, and 742 studies available for those aged over 65 years old." - Anonymous Online Contributor
Are recruitment efforts ongoing for this medical investigation?
"Affirmative. According to clinicaltrials.gov, this experiment is currently conscripting test subjects - it was initially uploaded on September 30th 2019 with its most recent update being November 15 2021. It requires 3 individuals from one medical centre for participation in the trial." - Anonymous Online Contributor
What is the total enrollment number for this research endeavor?
"Affirmative. Clinicaltrials.gov displays data affirming the recruitment of patients for this trial, which was first posted on September 30th 2019 and subsequently updated November 15th 2021. The medical study requires 3 people to be enrolled at a single location." - Anonymous Online Contributor
What criteria must be met in order for a person to qualify as a participant in this medical experiment?
"The trial is searching for 3 individuals aged between 22 and 65 with a spinal cord injury that meet the following criteria: gender agnostic, ISNCSCI motor scores of 0-2 (non-functional) on their fingers and ISNCSCI sensory scores of 0 - 2 (not normal) on the palmar side, ability to undertake upper limb electrodiagnostic & nerve conduction studies, at least one year post SCI trauma, English proficiency to follow verbal commands in testing sessions as well as understanding study goals/ procedures and providing consent for participation. Additionally, those eligible must demonstrate typical amplitude, latency & conduction velocity in dist" - Anonymous Online Contributor