Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury

Study Overview
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Brief Summary
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Stimulation of the spinal cord may induce the growth and reorganization of neural pathways leading to the re-animation of paralyzed limbs. Growing evidence indicates that electrical spinal cord stimulation improves motor functions immediately via modulating the excitability of spinal circuitry in patients with spinal cord injury. Recently, a novel, non-invasive, well-tolerated and painless transcutaneous electrical stimulation strategy was demonstrated to be effective for improving lower limb motor function in healthy individuals and in patients with spinal cord injury. The investigators hypothesize that transcutaneous cervical electrical stimulation can enhance conscious motor control and functions of hand and arm via neuromodulation of spinal network. This study is a prospective efficacy trial of transcutaneous cervical electrical stimulation for improving upper limb function in patients with traumatic or degenerative cervical spinal cord injury. Transcutaneous electrical spinal stimulation device is not regulated by the United States Food and Drug Administration for treatment of spinal cord injury. The interventions include either transcutaneous cervical spinal electrical stimulation combined with physical therapy or physical therapy only. The order of the interventions will be randomized for each subject in a delayed cross-over design. Total duration of the study is 6 months, including 4 weeks baseline measurements, 8 weeks intervention and 12 weeks follow-up. Both immediate and lasting improvements in hand motor and sensory function via transcutaneous cervical spinal stimulation will be evaluated.

Official Title
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Activity Dependent Rehabilitation Via Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury

Conditions
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Spinal Cord Injury Cervical, Upper Extremity Dysfunction

Intervention / Treatment
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* Device: Transcutaneous spinal stimulation
* Other: Physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cervical (C7 or higher) spinal cord injury at least 1-year duration Incomplete spinal cord injury (American Spinal Injury Association Impairment Scale (AIS) C or D) Between 21 and 70 years of age Difficulty with hand functions in activities of daily living (e.g. dressing, grooming, feeding) Stable medical condition without cardiopulmonary disease or frequent autonomic dysreflexia that would contraindicate participation in upper extremity rehabilitation or testing activities Capable of performing simple cued motor tasks Ability to attend 2 to 5 sessions of weekly physical therapy sessions and testing activities Adequate social support to be able to participate in weekly training and assessment sessions for the duration of 6 months within the study period. Ability to read and speak English Exclusion Criteria: Autoimmune etiology of spinal cord dysfunction/injury History of additional neurologic disease, such as stroke, multiple sclerosis, traumatic brain injury, etc. Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.) Rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.) Significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation. Active cancer Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention Unhealed fracture, contracture, pressure sore, or urinary tract infection or other illnesses that might interfere with upper extremity rehabilitation or testing activities Any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician Pregnancy Tendon or nerve transfer surgery in the upper limbs Botulinum toxin injections in the prior 6 months Dependent on ventilation support Implanted stimulator (e.g. vagus nerve stimulator, pacemaker, cochlear implant, etc). Has depression or anxiety based on Patient Health Questionnaire and General Anxiety Disorder-7 item Questionnaire Diagnosed with syringomyelia Alcohol and/or drug abuse. Cognitive impairment based on Short Portable Mental Status Questionnaire Unable to read and/or comprehend the consent form. Unable to understand the instructions given as part of the study.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transcutaneous spinal stimulation & Physical therapy<br>Transcutaneous cervical electrical stimulation combined with physical therapy that targets rehabilitation of upper extremity functions | Device: Transcutaneous spinal stimulation<br>* Non-invasive electrical stimulation of cervical spinal cord over the skin<br>Other: Physical therapy<br>* Physical therapy to improve arm and hand functions<br>* Other names: Exercise therapy;|
| Active Comparator: Physical therapy only<br>Physical therapy that targets rehabilitation of upper extremity functions | Other: Physical therapy<br>* Physical therapy to improve arm and hand functions<br>* Other names: Exercise therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graded and Redefined Assessment of Strength, Sensibility and Prehension test (GRASSP test) | GRASSP is a clinical impairment measurement tool that quantifies hand impairment caused by cervical spinal cord injury. The tool measures three domains of function, including strength (manual muscle strength testing), sensibility (Semmes Weinstein monofilament sensation test) and prehension (ability and performance to generate various grasp and pinch movements using water bottle, jar, key, pegs, coins and nuts). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination | Standard neurologic examination that is routinely used to determine the levels and severity of spinal cord injury. Includes manual muscle strength testing and dermatomal light touch and pin prick sensory examination. | 6 months | 
| Grip and pinch strength | Hand strength measurement by grip and pinch dynamometry | 6 months | 
| Numeric Pain Rating Scale | Patient reported pain rating | 6 months | 
| Penn Spasm score | Patient reported spasm rating | 6 months | 
| Spinal Cord Independence Measure | Clinician-administered disability questionnaire for patients with spinal cord lesions | 6 months | 
| WHO-Quality of life - BREF | Patient reported quality of life scale | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal electrical stimulation