Restoration of Hand Function in Cervical SCI
ConditionSpinal Cord Injury Cervical
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMetroHealth Medical Center
About this trial
The purpose of this study is to evaluate a new method of restoring hand function to people with spinal cord injury. Current methods to restore hand function include tendon transfers and nerve transfers. This study will evaluate the grasp strength that can be achieved with a small, implantable stimulator.
KeyGrip is an investigational device that works by activating paralyzed muscles with low levels of electrical current. The word "investigational" means the study device is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA) for the use being studied.
Hypothesis. The study is designed to explore the feasibility of this approach; no hypothesis is planned at this stage
Eligibility criteria
Qualifiers
Male or female adults 18 years of age or older;
Cervical spinal cord injury as defined by: a) International Standard for Neurological Classification of Spinal Cord Injury motor level of C1 through C7; and b) American Spinal Injury Association Impairment Scale (AIS) grade A, B, or C;
Six months or more post-injury (neurostability);
Neurologically stable following any nerve transfers affecting the upper extremity (typically, one-year post-surgery);
Disqualifiers
Other neurological conditions (Multiple Sclerosis, diabetes with peripheral nerve involvement);
Associated peripheral nerve / brachial plexus injury;
Progressive Spinal Cord Injury;
Active implantable medical device (AIMD) such as a pacemaker or defibrillator;
Trial design
Treatments tested in this trial
- Key Grip
- Implanted Key Grip Electrodes
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov