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Restoring High Dimensional Hand Function to Persons With Chronic High Tetraplegia

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ClinicalTrials.gov Identifier: NCT03482310
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : June 18, 2018
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

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.



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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
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
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
Principal Investigator: Abidemi B. Ajiboye, PhD Louis Stokes VA Medical Center, Cleveland, OH

Additional Information:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03482310     History of Changes
Other Study ID Numbers: A2654-R
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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:
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