N/A
N=1
Restoring High Dimensional Hand Function to Persons With Chronic High Tetraplegia
Spinal Cord Injuries · Tetraplegia · Quadriplegia
Bottom Line
View on ClinicalTrials.gov: NCT03482310 ↗Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Ability to Form Appropriate Grasp Patterns — 78.75 percentage of correct grasps formed
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Using the Neuroport cortical recording array to determine the desired grasp pattern for a functional electrical stimulation (FES) system (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ability to Form Appropriate Grasp Patterns |
78.75 | — |
Summary
This study is for people who have a paralyzed arm and hand from a spinal cord injury, who have also received a recording electrode array in the brain as part of the BrainGate study. The study will look at the ability of these participants to control different grasping patterns of the hand, both in virtual reality and in his/her actual hand. Movement of the participant's hand is controlled by a functional electrical stimulation (FES) system, which involves small electrodes implanted in the arm, shoulder and hand that use small electrical currents to activate the appropriate muscles.
Eligibility Criteria
Inclusion Criteria
- Cognitively intact (able to follow instructions)
- A spinal cord injury resulting in at least partial arm paralysis
- Participant in BrainGate2 clinical trial, having already received an intracortical array and demonstrated the ability to use the neural signals to control a cursor on a monitor.
Exclusion Criteria
- Profound visual impairments
- Participant in BrainGate2 clinical trial with insufficient recordable neural signals (such that the researchers cannot decode a movement intention command signal)
Data sourced from ClinicalTrials.gov (NCT03482310). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.