Restoring High Dimensional Hand Function to Persons With Chronic High Tetraplegia

Spinal Cord Injuries Clinical Trial

Official title:

Restoring High Dimensional Hand Function to Persons With Chronic High Tetraplegia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03482310
• Other study ID #: A2654-R
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Quadriplegia
• Spinal Cord Injuries
• Tetraplegia

Intervention

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

Locations

Country	Name	City	State
United States	Louis Stokes VA Medical Center, Cleveland, OH	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Case Western Reserve University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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