Trial Outcomes & Findings for Cervical Transcutaneous SCS for TBI (NCT NCT07147816)
NCT ID: NCT07147816
Last Updated: 2026-07-15
Results Overview
Isometric maximum voluntary contraction (MVC) force of shoulder flexion, shoulder extension, elbow flexion, elbow extension, hand grip and finger pinch under transcutaneous spinal cord stimulation ON and OFF conditions. MVC force was compared across transcutaneous spinal cord stimulation ON and OFF conditions within the same experimental session, (tSCS ON/tSCS OFF - 1)\*100.
TERMINATED
NA
14 participants
Immediately during tSCS ON and tSCS OFF conditions within a single experimental session
2026-07-15
Participant Flow
Participant milestones
| Measure |
Transcutaneous Electrical Stimulation of the Cervical Spinal Cord (tSCS) - TBI
Participants with traumatic brain injury (TBI) received spinal cord stimulation delivered through a non-invasive electrode (tSCS). The immediate assistive effects of tSCS on motor control were assessed in the TBI cohort (TSCS05 and TSCS14).
|
Transcutaneous Electrical Stimulation of the Cervical Spinal Cord (tSCS) - Healthy Controls
Able-bodied participants received transcutaneous spinal cord stimulation (tSCS). The immediate assistive effects of tSCS on motor control and proprioception were assessed in the able-bodied cohort.
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|---|---|---|
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Overall Study
STARTED
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2
|
12
|
|
Overall Study
COMPLETED
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2
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cervical Transcutaneous SCS for TBI
Baseline characteristics by cohort
| Measure |
Transcutaneous Electrical Stimulation of the Cervical Spinal Cord (tSCS) - TBI
n=2 Participants
Participants with traumatic brain injury (TBI) received spinal cord stimulation delivered through a non-invasive electrode (tSCS). The immediate assistive effects of tSCS on motor control were assessed in the TBI cohort (TSCS05 and TSCS14).
|
Transcutaneous Electrical Stimulation of the Cervical Spinal Cord (tSCS) - Healthy Controls
n=12 Participants
Participants received transcutaneous spinal cord stimulation (tSCS) delivered through a non-invasive electrode placed over the back of the neck, serving as the stimulating (depolarizing) electrode, and two electrodes positioned over the iliac crests, serving as return electrodes. The effects of tSCS on motor control were assessed in able-bodied participants. Additionally, the effects of tSCS on proprioception were evaluated in the able-bodied cohort.
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Total
n=14 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=20 Participants
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0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Handedness
left-handed
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Handedness
right-handed
|
0 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Handedness
ambidextrous
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Immediately during tSCS ON and tSCS OFF conditions within a single experimental sessionPopulation: Strength was not assessed when weakness was not identified, as pre-specified in the Study Protocol. Accordingly, strength was not assessed in the Control Arm/Group. Shoulder flexion, shoulder extension, elbow flexion, and elbow extension strength were not assessed in these TBI participants, as they did not show clear impairments in those joints. For the TBI Arm/Group, pinch strength was assessed in TSCS05 and TSCS14, and grip strength was assessed only in TSCS14.
Isometric maximum voluntary contraction (MVC) force of shoulder flexion, shoulder extension, elbow flexion, elbow extension, hand grip and finger pinch under transcutaneous spinal cord stimulation ON and OFF conditions. MVC force was compared across transcutaneous spinal cord stimulation ON and OFF conditions within the same experimental session, (tSCS ON/tSCS OFF - 1)\*100.
Outcome measures
| Measure |
Transcutaneous Electrical Stimulation of the Cervical Spinal Cord (tSCS) - TBI
n=2 Participants
Participants with traumatic brain injury (TBI) received spinal cord stimulation delivered through a non-invasive electrode (tSCS). The immediate assistive effects of tSCS on motor control were assessed in the TBI cohort (TSCS05 and TSCS14).
|
Transcutaneous Electrical Stimulation of the Cervical Spinal Cord (tSCS) - Healthy Controls
Participants received transcutaneous spinal cord stimulation (tSCS) delivered through a non-invasive electrode placed over the back of the neck, serving as the stimulating (depolarizing) electrode, and two electrodes positioned over the iliac crests, serving as return electrodes. The effects of tSCS on motor control were assessed in able-bodied participants. Additionally, the effects of tSCS on proprioception were evaluated in the able-bodied cohort.
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|---|---|---|
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Strength
Hand grip
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30.52 percentage of change
Interval 30.52 to 30.52
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—
|
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Strength
Finger pinch
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34.19 percentage of change
Interval 22.22 to 46.16
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—
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SECONDARY outcome
Timeframe: Immediately during tSCS ON and tSCS OFF conditions within a single experimental sessionPopulation: Movement smoothness was not assessed when motor control deficits were not identified, as pre-specified in the Study Protocol. Accordingly, movement smoothness was not assessed in the Control Arm/Group, as these participants did not show motor control deficits.
An exoskeleton robot (KINARM) was used to assess arm movement smoothness during two-dimensional (2D) reaching tasks under transcutaneous spinal cord stimulation ON and OFF conditions. Movement smoothness was quantified using log-dimensionless jerk of the hand velocity. Log-dimensionless jerk was compared across transcutaneous spinal cord stimulation ON and OFF conditions within the same experimental session, (tSCS ON/tSCS OFF - 1)\*100.
Outcome measures
| Measure |
Transcutaneous Electrical Stimulation of the Cervical Spinal Cord (tSCS) - TBI
n=2 Participants
Participants with traumatic brain injury (TBI) received spinal cord stimulation delivered through a non-invasive electrode (tSCS). The immediate assistive effects of tSCS on motor control were assessed in the TBI cohort (TSCS05 and TSCS14).
|
Transcutaneous Electrical Stimulation of the Cervical Spinal Cord (tSCS) - Healthy Controls
Participants received transcutaneous spinal cord stimulation (tSCS) delivered through a non-invasive electrode placed over the back of the neck, serving as the stimulating (depolarizing) electrode, and two electrodes positioned over the iliac crests, serving as return electrodes. The effects of tSCS on motor control were assessed in able-bodied participants. Additionally, the effects of tSCS on proprioception were evaluated in the able-bodied cohort.
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|---|---|---|
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Movement Smoothness
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26 percent change (%)
Interval 17.0 to 35.0
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—
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SECONDARY outcome
Timeframe: Immediately during tSCS ON and tSCS OFF conditions within a single experimental sessionPopulation: Joint velocity was not assessed when motor control deficits were not identified, as pre-specified in the Study Protocol. Accordingly, joint velocity was not assessed in the Control Arm/Group, as these participants did not show motor control deficits.
An exoskeleton robot (KINARM) was used to assess arm joint velocity during two-dimensional (2D) reaching tasks under transcutaneous spinal cord stimulation ON and OFF conditions. Arm joint velocity was quantified as the ratio between the time required to move the arm from an initial position to a final target and the distance between the positions (m/s). Arm joint velocity was compared across transcutaneous spinal cord stimulation ON and OFF conditions within the same experimental session, (tSCS ON/tSCS OFF - 1)\*100.
Outcome measures
| Measure |
Transcutaneous Electrical Stimulation of the Cervical Spinal Cord (tSCS) - TBI
n=2 Participants
Participants with traumatic brain injury (TBI) received spinal cord stimulation delivered through a non-invasive electrode (tSCS). The immediate assistive effects of tSCS on motor control were assessed in the TBI cohort (TSCS05 and TSCS14).
|
Transcutaneous Electrical Stimulation of the Cervical Spinal Cord (tSCS) - Healthy Controls
Participants received transcutaneous spinal cord stimulation (tSCS) delivered through a non-invasive electrode placed over the back of the neck, serving as the stimulating (depolarizing) electrode, and two electrodes positioned over the iliac crests, serving as return electrodes. The effects of tSCS on motor control were assessed in able-bodied participants. Additionally, the effects of tSCS on proprioception were evaluated in the able-bodied cohort.
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|---|---|---|
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Joint Velocity
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7.07 percent change (%)
Full Range 7.23 • Interval 1.96 to 12.18
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—
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SECONDARY outcome
Timeframe: Immediately during tSCS ON condition within a single experimental sessionPopulation: Pain was systematically assessed across all participants because of its priority for clinical translation. Discomfort was not systematically assessed; therefore, no discomfort data are available to report.
Discomfort and/or pain experienced by participants during transcutaneous spinal cord stimulation was assessed using a self-reported 0-10 scale, where low values indicate low discomfort/pain, and high values indicate high discomfort/pain.
Outcome measures
| Measure |
Transcutaneous Electrical Stimulation of the Cervical Spinal Cord (tSCS) - TBI
n=2 Participants
Participants with traumatic brain injury (TBI) received spinal cord stimulation delivered through a non-invasive electrode (tSCS). The immediate assistive effects of tSCS on motor control were assessed in the TBI cohort (TSCS05 and TSCS14).
|
Transcutaneous Electrical Stimulation of the Cervical Spinal Cord (tSCS) - Healthy Controls
n=12 Participants
Participants received transcutaneous spinal cord stimulation (tSCS) delivered through a non-invasive electrode placed over the back of the neck, serving as the stimulating (depolarizing) electrode, and two electrodes positioned over the iliac crests, serving as return electrodes. The effects of tSCS on motor control were assessed in able-bodied participants. Additionally, the effects of tSCS on proprioception were evaluated in the able-bodied cohort.
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|---|---|---|
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Discomfort/Pain
pain sensation
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0 scores
Interval 0.0 to 0.0
|
0 scores
Interval 0.0 to 0.0
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SECONDARY outcome
Timeframe: Immediately during tSCS ON and tSCS OFF conditions within a single experimental sessionPopulation: Joint synergies were not assessed when abnormal synergies was not identified, as pre-specified in the Study Protocol. Accordingly, the two TBI participants enrolled in this study presented with mild upper limb motor impairments, primarily affecting hand function and fine motor control of the arm. Joint synergies were not assessed in any TBI participant. Joint synergies were also not assessed in the Control Arm/Group, as these participants did not present with abnormal synergies.
The "movement combining synergies" and "movement out-of-synergies" subcomponents of the Fugl-Meyer Assessment (FMA) for upper extremity motor function will be used to quantify joint synergies under transcutaneous spinal cord stimulation ON and OFF conditions. The Fugl-Meyer Assessment (FMA) is a performance-based impairment index designed to evaluate upper extremity motor function in individuals with post-stroke hemiparesis. The FMA for upper extremity motor function consists of 33 items, each scored with 0-2 points (0 = cannot perform task, 2 = fully performs task), resulting a maximum score of 66 points . For this study, the subscores from the 'movement combining synergies' and 'movement out-of-synergies' components will be summed to quantify changes in joint synergies. FMA subscores will be compared across transcutaneous spinal cord stimulation ON and OFF conditions within the same experimental session, (tSCS ON/tSCS OFF - 1)\*100.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Immediately during tSCS ON and tSCS OFF conditions within a single experimental sessionPopulation: Spasticity was not assessed when spasticity was not identified, as pre-specified in the Study Protocol. Accordingly, the two TBI participants enrolled in this study presented with mild upper limb motor impairments, primarily affecting hand function and fine motor control of the arm. Spasticity was not assessed in any TBI participant. Spasticity was also not assessed in the Control Arm/Group, as these participants did not present with spasticity.
Spasticity will be measured using the Modified Ashworth Scale (MAS) for the following muscle groups under transcutaneous spinal cord stimulation ON and OFF conditions: shoulder flexors, shoulder extensors, shoulder abductors, shoulder adductors, elbow flexors, elbow extensors, wrist pronators, wrist supinators, wrist flexors, wrist extensors, and finger flexors/extensors. The MAS is a 0-4 ordinal scale that quantifies resistance to passive stretch as a measure of spasticity, with lower scores indicating minimal spasticity and higher scores indicating marked spasticity. The MAS scores will be summed across all muscle groups to create an overall metric quantifying spasticity. MAS scores will be compared across transcutaneous spinal cord stimulation ON and OFF conditions within the same experimental session, (tSCS ON/tSCS OFF - 1)\*100.
Outcome measures
Outcome data not reported
Adverse Events
Transcutaneous Electrical Stimulation of the Cervical Spinal Cord (tSCS) - TBI
Transcutaneous Electrical Stimulation of the Cervical Spinal Cord (tSCS) - Healthy Controls
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Transcutaneous Electrical Stimulation of the Cervical Spinal Cord (tSCS) - TBI
n=2 participants at risk
Participants with traumatic brain injury (TBI) received spinal cord stimulation delivered through a non-invasive electrode (tSCS). The immediate assistive effects of tSCS on motor control were assessed in the TBI cohort (TSCS05 and TSCS14).
|
Transcutaneous Electrical Stimulation of the Cervical Spinal Cord (tSCS) - Healthy Controls
n=12 participants at risk
Participants received transcutaneous spinal cord stimulation (tSCS) delivered through a non-invasive electrode placed over the back of the neck, serving as the stimulating (depolarizing) electrode, and two electrodes positioned over the iliac crests, serving as return electrodes. The effects of tSCS on motor control were assessed in able-bodied participants. Additionally, the effects of tSCS on proprioception were evaluated in the able-bodied cohort.
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|---|---|---|
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Musculoskeletal and connective tissue disorders
Soreness under the right arm after the experimental session
|
0.00%
0/2 • During a single session, from the start until completion of that session; a session lasted up to 4 hours.
|
8.3%
1/12 • During a single session, from the start until completion of that session; a session lasted up to 4 hours.
|
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Skin and subcutaneous tissue disorders
"Needle-pricking" sensations at the site where the cathode electrode was positioned
|
0.00%
0/2 • During a single session, from the start until completion of that session; a session lasted up to 4 hours.
|
8.3%
1/12 • During a single session, from the start until completion of that session; a session lasted up to 4 hours.
|
Additional Information
Roberto Martins de Freitas, Ph.D.
University of Pittsburgh
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place