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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical therapy only (Arm A) | Active Comparator | Physical therapy that targets the rehabilitation of upper extremity functions |
|
| Transcutaneous cervical electrical stimulation combined with physical therapy (Arm B) | Experimental | Application of Transcutaneous cervical electrical stimulation combined with physical therapy that targets the rehabilitation of upper extremity functions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous spinal stimulation | Device | Non-invasive electrical stimulation of cervical spinal cord over the skin |
|
| 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: 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chet T Moritz, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 981095 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 (Cross-over Intervention arm sequence: AB) | The sequence of cross-arm intervention for Group 1 will be as follows: "Physical therapy only (Arm A) first" and "Transcutaneous Spinal Cord Stimulation combined with Physical Therapy (Arm B) second." |
| FG001 | Group 2 (Cross-over Intervention arm sequence: BA) | The sequence of cross-arm intervention for Group 2 will be as follows: "Transcutaneous Spinal Cord Stimulation combined with Physical Therapy (Arm B) first" and "Physical therapy only (Arm A) second." |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 (Cross-over Intervention arm sequence: AB) - Active Comparator | The sequence of cross-arm intervention for Group 1 will be as follows: "Physical therapy only (Arm A) first" and "Transcutaneous Spinal Cord Stimulation combined with Physical Therapy (Arm B) second." Physical Therapy only is the active comparator intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score change before and after | 6 months |
|
6 years
The intervention carries a low risk of mild adverse events. For that reason, serious adverse events were not expected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: "Physical therapy only" | Physical therapy: Physical therapy to improve arm and hand functions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fatma Inanici | University of Washington | 2067872692 | finanici@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 22, 2022 | Jul 21, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 22, 2022 | Jul 21, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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Participants will be randomized into two groups:
Group 1.) Six weeks of "Physical therapy only" (Arm A) as the first intervention and then 6 weeks of "Transcutaneous spinal stimulation & Physical therapy" (Arm B) as the second intervention.
Group 2.) Six weeks of "Transcutaneous spinal stimulation & Physical therapy" (Arm B) as the first intervention, and then "Physical therapy only" (Arm A) as the second intervention.
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| Physical therapy | Other | Physical therapy to improve arm and hand functions |
|
|
| 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. | 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. | 6 months |
| Penn Spasm Score | Patient-reported spasm rating. Scores are mild (0), moderate (1), and severe (2). | 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. | 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. | 6 months |
| BG001 |
| Group 2 (Cross-over Intervention arm sequence: BA) - Experimental |
The sequence of cross-arm intervention for Group 2 will be as follows: "Transcutaneous Spinal Cord Stimulation combined with Physical Therapy (Arm B) first" and "Physical therapy only (Arm A) second." Transcutaneous Spinal Cord Stimulation, combined with physical therapy, is the experimental intervention. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| International Standards for Neurological Classification of SCI (ISNCSCI) | International Standards for Neurological Classification of Spinal Cord Injury 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Transcutaneous Spinal Cord Stimulation combined with Physical Therapy | All participants, when they receive Transcutaneous Spinal Cord Stimulation combined with Physical Therapy |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | kilogram | 6 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Secondary | Penn Spasm Score | Patient-reported spasm rating. Scores are mild (0), moderate (1), and severe (2). | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Arm B: "Transcutaneous spinal stimulation & Physical therapy" | Transcutaneous spinal stimulation: Non-invasive electrical stimulation of the cervical spinal cord over the skin combined with Physical therapy to improve arm and hand functions. | 0 | 15 | 0 | 15 | 0 | 15 |
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| D005791 |
| Patient Care |