Restoring High Dimensional Hand Function to Persons With Chronic High Tetraplegia
Primary Purpose
Spinal Cord Injuries, Tetraplegia, Quadriplegia
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Using the Neuroport cortical recording array to determine the desired grasp pattern for a functional electrical stimulation (FES) system
Sponsored by
About this trial
This is an interventional device feasibility trial for Spinal Cord Injuries focused on measuring Brain computer interface, electric stimulation
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)
Sites / Locations
- Louis Stokes VA Medical Center, Cleveland, OH
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cortical Control of Grasp Patterns
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03482310
First Posted
March 16, 2018
Last Updated
November 10, 2022
Sponsor
VA Office of Research and Development
Collaborators
Case Western Reserve University
1. Study Identification
Unique Protocol Identification Number
NCT03482310
Brief Title
Restoring High Dimensional Hand Function to Persons With Chronic High Tetraplegia
Official Title
Restoring High Dimensional Hand Function to Persons With Chronic High Tetraplegia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Why Stopped
Awaiting additional funding
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Case Western Reserve University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Tetraplegia, Quadriplegia
Keywords
Brain computer interface, electric stimulation
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cortical Control of Grasp Patterns
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Using the Neuroport cortical recording array to determine the desired grasp pattern for a functional electrical stimulation (FES) system
Intervention Description
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
Primary Outcome Measure Information:
Title
Ability to form appropriate grasp patterns
Description
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.
Time Frame
Through study completion, typically around 1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abidemi B. Ajiboye, PhD
Organizational Affiliation
Louis Stokes VA Medical Center, Cleveland, OH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louis Stokes VA Medical Center, Cleveland, OH
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We will not be sharing individual participant data.
Links:
URL
https://www.braingate.org
Description
Home site of BrainGate clinical trial
URL
https://rehabstudy.org
Description
Home site of ReHAB study
Learn more about this trial
Restoring High Dimensional Hand Function to Persons With Chronic High Tetraplegia
We'll reach out to this number within 24 hrs