Hand Function for Tetraplegia

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 known 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00890916
Study type	Interventional
Source	VA Office of Research and Development
Contact
Status	Completed
Phase	N/A
Start date	January 1, 2012
Completion date	May 1, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02574572` - Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury	Phase 1
Recruiting	`NCT05941819` - ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury	N/A
Completed	`NCT05265377` - Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury	N/A
Recruiting	`NCT02331979` - Improving Bladder Function in SCI by Neuromodulation	N/A
Completed	`NCT02777281` - Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI	N/A
Recruiting	`NCT02978638` - Electrical Stimulation for Continence After Spinal Cord Injury	N/A
Withdrawn	`NCT02237547` - Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury	Phase 1/Phase 2
Completed	`NCT02161913` - Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers	N/A
Completed	`NCT02262234` - Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study	Phase 1/Phase 2
Completed	`NCT01884662` - Virtual Walking for Neuropathic Pain in Spinal Cord Injury	N/A
Terminated	`NCT02080039` - Electrical Stimulation of Denervated Muscles After Spinal Cord Injury	N/A
Completed	`NCT01642901` - Zoledronic Acid in Acute Spinal Cord Injury	Phase 3
Completed	`NCT01471613` - Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury	Phase 1/Phase 2
Terminated	`NCT01433159` - Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury	Phase 2
Completed	`NCT02149511` - Longitudinal Morphometric Changes Following SCI
Completed	`NCT01467817` - Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)	N/A
Completed	`NCT01086930` - Early Intensive Hand Rehabilitation After Spinal Cord Injury	Phase 3
Completed	`NCT01025609` - Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury
Completed	`NCT00663663` - Telephone Intervention for Pain Study (TIPS)	N/A
Terminated	`NCT01005615` - Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury	Phase 1/Phase 2