Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Restoring High Dimensional Hand Function to Persons With Chronic High Tetraplegia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482310
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : March 17, 2020
Sponsor:
Collaborator:
Case Western Reserve University
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Tetraplegia Quadriplegia Device: Using the Neuroport cortical recording array to determine the desired grasp pattern for a functional electrical stimulation (FES) system Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Restoring High Dimensional Hand Function to Persons With Chronic High Tetraplegia
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

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




Primary Outcome Measures :
  1. Ability to form appropriate grasp patterns [ Time Frame: Through study completion, typically around 1 year ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482310


Contacts
Layout table for location contacts
Contact: Abidemi B Ajiboye, PhD (216) 368-6814 aba20@case.edu
Contact: William D Memberg (216) 791-3800 ext 820 6195 William.Memberg@va.gov

Locations
Layout table for location information
United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH Recruiting
Cleveland, Ohio, United States, 44106
Contact: Holly B Henry    216-791-3800 ext 4657    holly.henry@va.gov   
Contact: Neal S Peachey, PhD    (216) 421-3221    neal.peachey@va.gov   
Principal Investigator: Abidemi B. Ajiboye, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Case Western Reserve University
Investigators
Layout table for investigator information
Principal Investigator: Abidemi B. Ajiboye, PhD Louis Stokes VA Medical Center, Cleveland, OH

Additional Information:
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03482310    
Other Study ID Numbers: A2654-R
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will not be sharing individual participant data.

Layout table for additional information
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
Keywords provided by VA Office of Research and Development:
Brain computer interface
electric stimulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Quadriplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations
Signs and Symptoms