An interventional study of Transcutaneous spinal stimulation and Physical therapy in Spinal Cord Injury Cervical and Upper Extremity Dysfunction, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-11-04.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
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.
University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
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Exclusion Criteria:
Physical therapy that targets the rehabilitation of upper extremity functions
Other: Physical therapy
Application of Transcutaneous cervical electrical stimulation combined with physical therapy that targets the rehabilitation of upper extremity functions
Device: Transcutaneous spinal stimulation · Other: Physical therapy
Non-invasive electrical stimulation of cervical spinal cord over the skin
Physical therapy to improve arm and hand functions
Also known as: Exercise therapy
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
We use advertisement flyers and information sheets that will be clearly displayed in the neurosurgery and rehabilitation outpatient departments at the University of Washington, for all to see. Recruitment began on December 1, 2017, and concluded on December 1, 2023.
| Milestone | Group 1 (Cross-over Intervention arm sequence: AB) | Group 2 (Cross-over Intervention arm sequence: BA) |
|---|---|---|
| Started | 7 | 8 |
| Completed | 5 | 6 |
| Not completed | 2 | 2 |
| Withdrew: Pandemic | 2 | 2 |
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.
| score change before and after | Physical Therapy only | Transcutaneous Spinal Cord Stimulation combined with Physical Therapy |
|---|---|---|
| Graded and Redefined Assessment of Strength, Sensibility and Prehension Test (GRASSP Test) | 4.5 ± 4.1 | 19.4 ± 6.3 |
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.
| score on a scale | Physical Therapy only | Transcutaneous Spinal Cord Stimulation combined with Physical Therapy |
|---|---|---|
| Subscore 1: Myotomal-based Motor Examination | 0.5 ± 0.8 | 5.5 ± 2.3 |
| Subscale 2: The Dermatomal-based Sensory Examination | 1.6 ± 5.2 | 6.4 ± 9.5 |
Hand strength measurement by dynamometry. The change in strength (improvement) before and at the end of each intervention arm is calculated.
| kilogram | Physical therapy only | Transcutaneous Spinal Cord Stimulation combined with Physical Therapy |
|---|---|---|
| Grip and Pinch Strength | 3 ± 2 | 12 ± 4 |
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.
| score on a scale | physical therapy only | Transcutaneous Spinal Cord Stimulation combined with Physical Therapy |
|---|---|---|
| Numeric Pain Rating Scale | 4.0 ± 1.1 | 2.0 ± 0.5 |
Patient-reported spasm rating. Scores are mild (0), moderate (1), and severe (2).
| score on a scale | Physical therapy only | Transcutaneous Spinal Cord Stimulation combined with Physical Therapy |
|---|---|---|
| Penn Spasm Score | 1.5 ± 0.5 | 1.0 ± 0 |
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.
| score on a scale | Physical therapy only | ranscutaneous Spinal Cord Stimulation combined with Physical Therapy |
|---|---|---|
| Spinal Cord Independence Measure (SCIM) | 0.2 ± 0.4 | 3.2 ± 2.2 |
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.
| score on a scale | Physical therapy only | Transcutaneous Spinal Cord Stimulation combined with Physical Therapy |
|---|---|---|
| World Health Organization-Quality of Life - (WHO-QoL-BREF) | 4.3 ± 7.7 | 12.5 ± 8.9 |
Collected over 6 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: "Physical therapy only" | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Arm B: "Transcutaneous spinal stimulation & Physical therapy" | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(years) | Group 1 (Cross-over Intervention arm sequence: AB) - Active Comparator | Group 2 (Cross-over Intervention arm sequence: BA) - Experimental | Total |
|---|---|---|---|
| Mean | 59 ± 14 | 60 ± 6 | 59 ± 10 |
| Sex: Female, Male(Participants) | Group 1 (Cross-over Intervention arm sequence: AB) - Active Comparator | Group 2 (Cross-over Intervention arm sequence: BA) - Experimental | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 6 | 6 | 12 |
| Race and Ethnicity Not Collected(Participants) | Group 1 (Cross-over Intervention arm sequence: AB) - Active Comparator | Group 2 (Cross-over Intervention arm sequence: BA) - Experimental | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Group 1 (Cross-over Intervention arm sequence: AB) - Active Comparator | Group 2 (Cross-over Intervention arm sequence: BA) - Experimental | Total |
|---|---|---|---|
| United States | 7 | 8 | 15 |
| International Standards for Neurological Classification of SCI (ISNCSCI)(units on a scale) | Group 1 (Cross-over Intervention arm sequence: AB) - Active Comparator | Group 2 (Cross-over Intervention arm sequence: BA) - Experimental | Total |
|---|---|---|---|
| Subscale 1: Myotomal-based Motor Examination | 50.1 ± 21.5 | 49.8 ± 15.0 | 49.9 ± 17.8 |
| Subscale 2:Dermatomal-based Sensory Examination | 111.0 ± 43.3 | 113.8 ± 36.4 | 112.4 ± 35.8 |
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