Trial Outcomes & Findings for Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury (NCT NCT03184792)
NCT ID: NCT03184792
Last Updated: 2025-11-04
Results Overview
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.
COMPLETED
NA
15 participants
6 months
2025-11-04
Participant Flow
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.
Participant milestones
| Measure |
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."
|
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."
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
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."
|
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."
|
|---|---|---|
|
Overall Study
Pandemic
|
2
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1 (Cross-over Intervention arm sequence: AB) - Active Comparator
n=7 Participants
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.
|
Group 2 (Cross-over Intervention arm sequence: BA) - Experimental
n=8 Participants
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.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 14 • n=7 Participants
|
60 years
STANDARD_DEVIATION 6 • n=8 Participants
|
59 years
STANDARD_DEVIATION 10 • n=15 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=7 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=7 Participants
|
6 Participants
n=8 Participants
|
12 Participants
n=15 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
7 participants
n=7 Participants
|
8 participants
n=8 Participants
|
15 participants
n=15 Participants
|
|
International Standards for Neurological Classification of SCI (ISNCSCI)
Subscale 1: Myotomal-based Motor Examination
|
50.1 units on a scale
STANDARD_DEVIATION 21.5 • n=7 Participants
|
49.8 units on a scale
STANDARD_DEVIATION 15.0 • n=8 Participants
|
49.9 units on a scale
STANDARD_DEVIATION 17.8 • n=15 Participants
|
|
International Standards for Neurological Classification of SCI (ISNCSCI)
Subscale 2:Dermatomal-based Sensory Examination
|
111.0 units on a scale
STANDARD_DEVIATION 43.3 • n=7 Participants
|
113.8 units on a scale
STANDARD_DEVIATION 36.4 • n=8 Participants
|
112.4 units on a scale
STANDARD_DEVIATION 35.8 • n=15 Participants
|
PRIMARY outcome
Timeframe: 6 monthsGRASSP 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.
Outcome measures
| Measure |
Physical Therapy only
n=11 Participants
All participants, when they receive the "physical therapy only" intervention arm.
|
Transcutaneous Spinal Cord Stimulation combined with Physical Therapy
n=11 Participants
All participants, when they receive Transcutaneous Spinal Cord Stimulation combined with Physical Therapy
|
|---|---|---|
|
Graded and Redefined Assessment of Strength, Sensibility and Prehension Test (GRASSP Test)
|
4.5 score change before and after
Standard Deviation 4.1
|
19.4 score change before and after
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: 6 monthsInternational 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.
Outcome measures
| Measure |
Physical Therapy only
n=11 Participants
All participants, when they receive the "physical therapy only" intervention arm.
|
Transcutaneous Spinal Cord Stimulation combined with Physical Therapy
n=11 Participants
All participants, when they receive Transcutaneous Spinal Cord Stimulation combined with Physical Therapy
|
|---|---|---|
|
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
Subscore 1: Myotomal-based Motor Examination
|
0.5 score on a scale
Standard Deviation 0.8
|
5.5 score on a scale
Standard Deviation 2.3
|
|
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
Subscale 2: The Dermatomal-based Sensory Examination
|
1.6 score on a scale
Standard Deviation 5.2
|
6.4 score on a scale
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: 6 monthsHand strength measurement by dynamometry. The change in strength (improvement) before and at the end of each intervention arm is calculated.
Outcome measures
| Measure |
Physical Therapy only
n=11 Participants
All participants, when they receive the "physical therapy only" intervention arm.
|
Transcutaneous Spinal Cord Stimulation combined with Physical Therapy
n=11 Participants
All participants, when they receive Transcutaneous Spinal Cord Stimulation combined with Physical Therapy
|
|---|---|---|
|
Grip and Pinch Strength
|
3 kilogram
Standard Deviation 2
|
12 kilogram
Standard Deviation 4
|
SECONDARY outcome
Timeframe: 6 monthsPatient 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.
Outcome measures
| Measure |
Physical Therapy only
n=11 Participants
All participants, when they receive the "physical therapy only" intervention arm.
|
Transcutaneous Spinal Cord Stimulation combined with Physical Therapy
n=11 Participants
All participants, when they receive Transcutaneous Spinal Cord Stimulation combined with Physical Therapy
|
|---|---|---|
|
Numeric Pain Rating Scale
|
4.0 score on a scale
Standard Deviation 1.1
|
2.0 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 6 monthsPatient-reported spasm rating. Scores are mild (0), moderate (1), and severe (2).
Outcome measures
| Measure |
Physical Therapy only
n=11 Participants
All participants, when they receive the "physical therapy only" intervention arm.
|
Transcutaneous Spinal Cord Stimulation combined with Physical Therapy
n=11 Participants
All participants, when they receive Transcutaneous Spinal Cord Stimulation combined with Physical Therapy
|
|---|---|---|
|
Penn Spasm Score
|
1.5 score on a scale
Standard Deviation 0.5
|
1.0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 6 monthsClinician-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.
Outcome measures
| Measure |
Physical Therapy only
n=11 Participants
All participants, when they receive the "physical therapy only" intervention arm.
|
Transcutaneous Spinal Cord Stimulation combined with Physical Therapy
n=11 Participants
All participants, when they receive Transcutaneous Spinal Cord Stimulation combined with Physical Therapy
|
|---|---|---|
|
Spinal Cord Independence Measure (SCIM)
|
0.2 score on a scale
Standard Deviation 0.4
|
3.2 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 6 monthsPatient-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.
Outcome measures
| Measure |
Physical Therapy only
n=11 Participants
All participants, when they receive the "physical therapy only" intervention arm.
|
Transcutaneous Spinal Cord Stimulation combined with Physical Therapy
n=11 Participants
All participants, when they receive Transcutaneous Spinal Cord Stimulation combined with Physical Therapy
|
|---|---|---|
|
World Health Organization-Quality of Life - (WHO-QoL-BREF)
|
4.3 score on a scale
Standard Deviation 7.7
|
12.5 score on a scale
Standard Deviation 8.9
|
Adverse Events
Arm A: "Physical therapy only"
Arm B: "Transcutaneous spinal stimulation & Physical therapy"
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place