N/A N=10 Treatment

Hand Function for Tetraplegia

Spinal Cord Injury · Tetraplegia

Bottom Line

View on ClinicalTrials.gov: NCT00890916 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2017

Primary outcome: Primary: Grasp Release Test - Test of Functional Ability to Pick up and Move Objects — 2; 5.5 Number of Completions

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: FIRSTHAND System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Nov 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Grasp Release Test - Test of Functional Ability to Pick up and Move Objects	2; 5.5	—

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.

Eligibility Criteria

Inclusion Criteria

cervical level spinal cord injury;
complete paralysis of fingers and thumbs;
voluntary shoulder motion;
electrically excitable forearm and hand musculature

Exclusion Criteria

extreme contractures of the joints;
skeletal immaturity;
extensive denervation in the forearm and hand;
poor surgical risk

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00890916). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.