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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Non-invasive electrical stimulation of cervical spinal cord over the skin
Physical therapy to improve arm and hand functions
University of Washington
Seattle, Washington, United States
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: strength (manual muscle strength testing), sensibility (Semmes-Weinstein monofilament sensation test), and prehension (ability and performance to generate various grasp and pinch movements using a water bottle, jar, key, pegs, coins, and nuts). The total score is calculated as the sum of the subscale scores. The minimum score is zero, and the maximum score is 232 points. Higher Scores mean a better outcome. Score change before and after each intervention is calculated.
Time frame: 6 months
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination Subscale 1: Myotomal-based Motor Examination - measures the motor function of the extremities. The minimum score is zero, and the maximum score is 100. Higher scores represent better outcomes. Subscale 2: The Dermatomal-based Sensory Examination - measures the sensory function of the whole body dermatomes. The minimum score is zero, and the maximum score is 224. Higher scores represent better outcomes.
Time frame: 6 months
Grip and Pinch Strength
Hand strength measurement by dynamometry. The change in strength (improvement) before and at the end of each intervention arm is calculated.
Time frame: 6 months
Numeric Pain Rating Scale
Patient reported pain rating on a 0 to 10 scale. The mean score change (improvement) before and at the end of each intervention arm is calculated. Zero means no pain, 10 means the worst pain one can imagine. Higher scores mean worse pain.
Time frame: 6 months
Penn Spasm Score
Patient-reported spasm rating. Scores are mild (0), moderate (1), and severe (2).
Time frame: 6 months
Spinal Cord Independence Measure (SCIM)
Clinician-administered disability questionnaire for patients with spinal cord lesions. The total SCIM scores range from 0 to 100. Higher scores mean better outcomes. Score change (improvement) relative to baseline or previous intervention arm is calculated.
Time frame: 6 months
World Health Organization-Quality of Life - (WHO-QoL-BREF)
Patient-reported quality of life scale. A higher score indicates a higher quality of life. Score change (improvement) relative to baseline or prior intervention arm is calculated.
Time frame: 6 months
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