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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Information provided by (Responsible Party): | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00890916 |
Purpose
The purpose of this study is to evaluate the effectiveness of an implanted stimulator for providing hand function to individuals with cervical level spinal cord injury. The device stimulates the paralyzed muscles of the hand and forearm. The user of the device controls the stimulation by moving muscles that are not paralyzed, such as a wrist or neck muscle. The ability of the user to pick up and move objects, as well as perform various activities such as eating, drinking, and writing.
| Condition | Intervention | Phase |
|---|---|---|
|
Spinal Cord Injury Tetraplegia |
Device: FIRSTHAND System |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Hand Function for Tetraplegia Using a Wireless Neuroprosthesis |
| Estimated Enrollment: | 7 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Receives implanted device for hand function.
|
Device: FIRSTHAND System
Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels.
|
The overall object of this research is to provide restored functional abilities to individuals with cervical-level spinal cord injury through the use of an advanced wireless myoelectrically controlled battery-powered implanted neuroprosthetic system know as the "FIRSTHAND" System. This restored function can enable the individual to achieve greater independence in activities of daily living and an improved quality of life. Electrical stimulation of paralyzed muscles will be used to generate functional movements. The movements will be controlled using myoelectric signals generated from muscles under the subject's voluntary control. The specific hypotheses of this study are: 1) at least 75% of all subjects will be able to manipulate at least one more object in the Grasp-Release Test when using the advanced neuroprosthesis compared to without the neuroprosthesis. 2) At least 75% of all subjects will demonstrate an increased level of independence in at least one functional activity when using the advanced neuroprosthesis. 3) At least 75% of all subjects will demonstrate an average neuroprosthesis usage of at least three days/week.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kevin L Kilgore, PhD | (216) 778-3801 | Kevin.Kilgore@va.gov |
| Contact: Anne M Bryden, OTR | (216) 778-3480 | amb31@case.edu |
| United States, Ohio | |
| VA Medical Center, Cleveland | Not yet recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Kevin L Kilgore, PhD 216-778-3801 Kevin.Kilgore@va.gov | |
| Contact: Holly Henry (216) 791-3800 ext 4657 holly.henry@va.gov | |
| Principal Investigator: Kevin L. Kilgore, PhD | |
| Principal Investigator: | Kevin L. Kilgore, PhD | VA Medical Center, Cleveland |
More Information
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00890916 History of Changes |
| Other Study ID Numbers: | A6027R |
| Study First Received: | April 27, 2009 |
| Last Updated: | February 1, 2012 |
| Health Authority: | United States: Federal Government |
|
spinal cord injury neuroprosthesis functional electrical stimulation quadriplegia |
|
Quadriplegia Spinal Cord Injuries Paralysis Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Spinal Cord Diseases Central Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
