ClinicalTrials.gg
CompletedNCT03482310Updated Feb 20, 2026Results posted

Restoring High Dimensional Hand Function to Persons With Chronic High Tetraplegia

An interventional study of Using the Neuroport cortical recording array to determine the desired grasp pattern for a functional electrical stimulation (FES) system in Spinal Cord Injuries, Tetraplegia and Quadriplegia, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-02-20.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 76 studies in Spinal Cord Injuries by VA Office of Research and Development — 17 open to participants now, 18 under way, 1 of them phase 3. Spinal Cord Injuries · VA Office of Research and Development.

Enrollment
67th of 69
1 · median 20
Started
2018
with 1 other
No phase
52 of 76
14 open now
Registered
39th of 76
by date

Among the 76 studies in Spinal Cord Injuries by VA Office of Research and Development, this one is the 67th largest by enrollment of the 69 interventional ones that give a count, is one of 2 that started in 2018, is one of 52 with no phase, and was the 39th registered.

Spinal Cord Injuries

2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.

Browse Spinal Cord Injuries studies →

Open to participants now

17 of the 76 studies in Spinal Cord Injuries by VA Office of Research and Development are open now, in 1 country. Recruiting first, the newest first:

12 more — sign in →

By country, each count listing its studies:

All 17 open studies →

Where they have run

Who these studies take

Of the 375 Spinal Cord Injuries studies recruiting now, 166 (44%) set no upper age limit and 158 (42%) stop at 75 or younger; 41 take children under 18; 52 take healthy volunteers.

This study: all sexes · no healthy volunteers.

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02

Study 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.

Read the detailed description

This work aims to advance Brain-Computer-Interfaces (BCls) to provide severely paralyzed persons a natural way of controlling Functional Electrical Stimulation (FES) neuroprostheses for restoring arm and dexterous hand movements. The prospect of using BCI technology for restoring arm and hand movements for reaching and grasping is based on the hypothesis that in a paralyzed human, there is a repeatable and understandable relationship between recordable brain activity and specific aspects of imagined arm movements. Many previous studies have attempted to understand the relationships between brain activity and arm and hand movements in able-bodied monkeys. Little is known about these same relationships in humans, and specifically within the context of trying to control an FES arm and complex hand system. This study will recruit persons who already have BCI and FES systems implanted to take advantage of the possibility of recording high resolution brain activity in human participants. Thus, from this study, we aim to gain a better understanding of how brain signals are related to specific aspects of arm and complex hand movements in humans with paralysis. Additionally, this study will test novel implementations of complex hand movement restoration in Veterans and other persons with chronic hand and arm paralysis.

03

Conditions studied

  • Spinal Cord Injuries
  • Tetraplegia
  • Quadriplegia

Keywords

  • Brain computer interface
  • electric stimulation
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    Cortical Control of Grasp Patterns

    Participants will be asked to think about holding different shaped objects, and the recorded cortical signal patterns will be decoded to match those grasp shapes

    Device: Using the Neuroport cortical recording array to determine the desired grasp pattern for a functional electrical stimulation (FES) system

Interventions

  • DeviceUsing the Neuroport cortical recording array to determine the desired grasp pattern for a functional electrical stimulation (FES) system

    Participants will be asked to think about holding different shaped objects, and the recorded cortical signal patterns will be decoded to match those grasp shapes

06

What researchers measure

Primary outcomes

  1. Ability to Form Appropriate Grasp Patterns

    The success rate for achieving a series of specified grasp patterns will be calculated. This will be a percentage of the target grasp patterns successfully achieved. The reported outcome is an average of the outcomes (mean +/- standard deviation) over the full assessment period

    Time frame: Outcomes were assessed on average every 3 months for the full time (4 years) that the participant was enrolled in the study.

07

Results

Posted Feb 20, 2026
Limitations and caveats
The trial enrolled one study participant, and hence the while the results demonstrate the possible benefit of the intervention, they do not necessarily represent an average expected benefit for any one individual.

Participant flow

Participant flow — Overall Study
MilestoneCortical Control of Grasp Patterns
Started1
Completed1
Not completed0

Outcome measures

PrimaryAbility to Form Appropriate Grasp Patterns

The success rate for achieving a series of specified grasp patterns will be calculated. This will be a percentage of the target grasp patterns successfully achieved. The reported outcome is an average of the outcomes (mean +/- standard deviation) over the full assessment period

Time frame:
Outcomes were assessed on average every 3 months for the full time (4 years) that the participant was enrolled in the study.
Reported as:
Mean · percentage of correct grasps formed
Ability to Form Appropriate Grasp Patterns
percentage of correct grasps formedCortical Control of Grasp Patterns
Ability to Form Appropriate Grasp Patterns78.75 ± 19.1

Adverse events

Collected over from enrollment until end of study, up to 48 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cortical Control of Grasp Patterns0/1 (0%)0/1 (0%)0/1 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Cortical Control of Grasp Patterns
<=18 years0
Between 18 and 65 years1
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Cortical Control of Grasp Patterns
Female0
Male1
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Cortical Control of Grasp Patterns
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White1
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • Louis Stokes VA Medical Center, Cleveland, OH
    Cleveland, Ohio 44106-1702, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — We will not be sharing individual participant data.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2018 to primary completion in Sep 2023, 63 months.

Results were first posted in Feb 2026, 2 years 4 months after primary completion.

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 63 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.

Registered
Mar 16, 2018
First posted
Mar 29, 2018
StartActual
Jun 1, 2018
Primary completionActual
Sep 30, 2023
CompletionActual
Sep 30, 2023
Results first posted
Feb 20, 2026
Last update
Feb 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03482310
Responsible party
Sponsor
First posted
Mar 29, 2018
Start date
Jun 1, 2018
Primary completion
Sep 30, 2023
Completion
Sep 30, 2023
Results posted
Feb 20, 2026
Last update
Feb 20, 2026

Study contacts

Abidemi B. Ajiboye, PhD
principal investigator · Louis Stokes VA Medical Center, Cleveland, OH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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