Restoring High Dimensional Hand Function to Persons With Chronic High Tetraplegia

NCT03482310 | Completed Results FDA Device

• 1 other identifier: A2654-R
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries; Tetraplegia; Quadriplegia

Keywords

Brain computer interface; electric stimulation

Outcome Measures

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

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

Study Arms (1)

Cortical Control of Grasp Patterns

EXPERIMENTAL

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

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

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

Cortical Control of Grasp Patterns

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Profound visual impairments
• Participant in BrainGate2 clinical trial with insufficient recordable neural signals (such that the researchers cannot decode a movement intention command signal)

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Case Western Reserve University: collaborator

Study Sites (1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

Location

Related Links

• Home site of BrainGate clinical trial
• Home site of ReHAB study

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

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.

Results Point of Contact

• Title: Dr. Abidemi Bolu Ajiboye
• Organization: Louis Stokes Cleveland VA Medical Center

abidemi.ajiboye@va.gov

2167913800

Study Officials

• Abidemi B. Ajiboye, PhD

  Louis Stokes VA Medical Center, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: March 29, 2018
• Study Start: June 1, 2018
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: February 20, 2026
• Results First Posted: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)