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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Key Grip
DeviceKeyGrip is an implantable peripheral nerve stimulator that is being studied for its ability to provide coordinated activation of innervated paralyzed muscles. KeyGrip will be configured to activate nerves of the upper extremity (arm and hand) in order to facilitate movements such as hand opening and/or closing
Implanted Key Grip Electrodes
DeviceThe KeyGrip System uses modified implanted wires (called "electrodes") that deliver stimulation to the muscles. These electrodes are also investigational.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: KeyGrip device implantationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Grasp-Release Test (GRT)
The GRT is a standardized pick-and-place test that evaluates two prehensile patterns (palmar and lateral grasp) using standardized objects of different weights and sizes that are designed to mimic objects encountered in daily life.
Time frame
baseline, 3-weeks post treatment, 12-weeks post treatment, 26-week post treatment, 52 weeks post treatmentSecondary outcomes
1
Grasp Strength
Lateral grasp strength is measured with and without the stimulation to identify changes in force that contribute to object acquisition and task performance Palmer Lateral grasp strength is measured with and without the stimulation to identify changes in force that contribute to object acquisition and task performance.
Time frame
baseline, 3 weeks post treatment, 12 weeks post treatment, 26-week post treatment, 52 weeks post treatment2
Activities of Daily Living Abilities Test
Functional goals will be identified by the participant. Participants will be evaluated in their level of independence in performing the tasks both with and without stimulation. Participants will rate the task on a scale of +(better), 0(same), - worse after they complete each task with the device on verse with the device off. This test allows us to measure the impact of the device on the participants individual functional goals.
Time frame
baseline, 12-weeks post treatment, 26-weeks post treatment, and 52-weeks post treatment3
Canadian Occupational Performance Measure (COPM)
The COPM is a client-centered assessment that measures a participant's perceived level of activity performance and satisfaction with that performance. The participant identifies the goals / activities and performance is assessed with and without the neuroprosthesis. Importance is rated on a 10-point scale with 1=not important at all and 10=extremely important Performance is rated on 10-point scale with 1=not able to do it at all and 10=able to do it extremely well Satisfaction is rated on a 10-point scale with 1=not satisfied and 10=extremely satisfied Change in importance, performance and satisfaction is calculated over time. Higher score is better outcome.
Time frame
baseline, 12-weeks post treatment, 26-weeks post treatment, and 52-weeks post treatmentSponsors and contacts
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Source ClinicalTrials.gov