Trial Outcomes & Findings for Restoring High Dimensional Hand Function to Persons With Chronic High Tetraplegia (NCT NCT03482310)

NCT ID: NCT03482310

Last Updated: 2026-02-20

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

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

Results posted on

2026-02-20

Participant Flow

Participant milestones

Participant milestones
Measure
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 Using 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
Overall Study
STARTED
1
Overall Study
COMPLETED
1
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Restoring High Dimensional Hand Function to Persons With Chronic High Tetraplegia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cortical Control of Grasp Patterns
n=1 Participants
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 Using 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
Age, Categorical
<=18 years
0 Participants
n=14 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=14 Participants
Age, Categorical
>=65 years
0 Participants
n=14 Participants
Sex: Female, Male
Female
0 Participants
n=14 Participants
Sex: Female, Male
Male
1 Participants
n=14 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=14 Participants
Race (NIH/OMB)
Asian
0 Participants
n=14 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=14 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=14 Participants
Race (NIH/OMB)
White
1 Participants
n=14 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=14 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=14 Participants

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure
Cortical Control of Grasp Patterns
n=1 Participants
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 Using 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
Ability to Form Appropriate Grasp Patterns
78.75 percentage of correct grasps formed
Standard Deviation 19.1

Adverse Events

Cortical Control of Grasp Patterns

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Abidemi Bolu Ajiboye

Louis Stokes Cleveland VA Medical Center

Phone: 2167913800

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place