Restoring High Dimensional Hand Function to Persons With Chronic High Tetraplegia

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries; Tetraplegia; Quadriplegia
• Intervention / Treatment: Device: Using the Neuroport cortical recording array to determine the desired grasp pattern for a functional electrical stimulation (FES) system

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through study completion, typically around 1 year

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Case Western Reserve University
• Investigators: Principal Investigator: Abidemi B. Ajiboye, PhD, Louis Stokes VA Medical Center, Cleveland, OH

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: March 16, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: electric stimulation; Brain computer interface
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Spinal Cord Injuries; Quadriplegia
• Other Study ID Numbers: A2654-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will not be sharing individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No