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The study was terminated due to administrative and logistical constraints following the Principal Investigator's transfer to another institution.
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| Name | Class |
|---|---|
| Chuck Noll Foundation | UNKNOWN |
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The goal of this study is to test the effects of non-invasive electrical stimulation of the spinal cord (called transcutaneous spinal cord stimulation, or tSCS) on arm and hand movement in people with motor impairments after a traumatic brain injury (TBI). Specifically, tSCS will be delivered using adhesive electrode pads placed on the skin over the upper back. The research team will measure how tSCS affects strength, movement control and muscle spasticity using different tests. Results of this study will help develop future treatments using an implanted (invasive) form of spinal cord stimulation to improve arm and hand function, helping people with TBI become more independent and improve their quality of life.
The main goal of this study is to assess the immediate effects of cervical transcutaneous spinal cord stimulation (tSCS) on arm and hand motor functions after traumatic brain injury (TBI). Specifically, the investigators will assess the immediate effects of tSCS across four different axes: arm and hand strength, arm motor control, joint synergies and spasticity.
The study hypothesis is that tSCS can immediately facilitate voluntary motor output of upper limb muscles by modulating residual descending drive to spinal motoneurons in TBI individuals. In this approach, tSCS targets large-diameter sensory fibers projecting onto motor neuron pools of upper limb muscles. Thus, by modulating the activity of these sensory fibers, the investigators hypothesize that tSCS can immediately increase the excitability of motoneurons receiving residual supraspinal input during movement execution.
Upon completion of this study, the investigators expect to build foundational evidence supporting the use of invasive (e.g. epidural spinal cord stimulation) and non-invasive SCS (tSCS) to improve upper limb motor function in individuals affected by chronic motor impairments after TBI. These results will lay the groundwork for future studies aimed at developing SCS neuroprosthetic devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous electrical stimulation of the cervical spinal cord (tSCS) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous electrical stimulation of the cervical spinal cord (tSCS) | Device | All participants enrolled in this group will receive non-invasive transcutaneous electrical stimulation of the cervical spinal cord (tSCS) while performing strength, spasticity and motor control assessment tasks. Researchers will assess the immediate effects of tSCS (within the same experimental session) on arm and hand movements in individuals with motor impairments caused by traumatic brain injury. |
| Measure | Description | Time Frame |
|---|---|---|
| Strength | Isometric maximum voluntary contraction (MVC) force of shoulder flexion, shoulder extension, elbow flexion, elbow extension, and hand grip under transcutaneous spinal cord stimulation ON and OFF conditions. MVC force will be compared across transcutaneous spinal cord stimulation ON and OFF conditions within the same experimental session. | Immediate (tSCS ON vs tSCS OFF condition within the same experimental session) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
TRAUMATIC BRAIN INJURY (TBI) SUBJECTS:
HEALTHY CONTROL SUBJECTS:
Exclusion Criteria:
TRAUMATIC BRAIN INJURY (TBI) SUBJECTS:
HEALTHY CONTROL SUBJECTS:
- Participants who have any serious disease or disorder (e.g. cancer, severe cardiac or respiratory disease, neurological conditions, etc.) or cognitive impairments that could affect their ability to participate in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Roberto M de Freitas, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34138648 | Background | de Freitas RM, Sasaki A, Sayenko DG, Masugi Y, Nomura T, Nakazawa K, Milosevic M. Selectivity and excitability of upper-limb muscle activation during cervical transcutaneous spinal cord stimulation in humans. J Appl Physiol (1985). 2021 Aug 1;131(2):746-759. doi: 10.1152/japplphysiol.00132.2021. Epub 2021 Jun 17. | |
| 35472720 | Background |
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Data may be shared with other researchers for the purpose of data analysis and collaboration.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 5, 2026 | Jun 1, 2026 | 4 | ||
| Jun 15, 2026 |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Prospective, non-randomized, open-label, descriptive, experimental study.
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| Immediate (tSCS ON vs tSCS OFF condition within the same experimental session) |
| Movement smoothness | An exoskeleton robot (KINARM) will be used to assess arm movement smoothness during two-dimensional (2D) reaching tasks under transcutaneous spinal cord stimulation ON and OFF conditions. Movement smoothness will be quantified using log-dimensionless jerk of the hand velocity. Log-dimensionless jerk will be compared across transcutaneous spinal cord stimulation ON and OFF conditions within the same experimental session. | Immediate (tSCS ON vs tSCS OFF condition within the same experimental session) |
| Joint velocity | An exoskeleton robot (KINARM) will be used to assess arm joint velocity during two-dimensional (2D) reaching tasks under transcutaneous spinal cord stimulation ON and OFF conditions. Arm joint velocity will be 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 will be compared across transcutaneous spinal cord stimulation ON and OFF conditions within the same experimental session. | Immediate (tSCS ON vs tSCS OFF condition within the same experimental session) |
| Discomfort/Pain | Discomfort and/or pain experienced by participants during transcutaneous spinal cord stimulation will be assessed using a self-reported 0-10 scale, where low values indicate low discomfort/pain, and high values indicate high discomfort/pain. | Immediate (while tSCS is ON) |
| Join 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. | Immediate (tSCS ON vs tSCS OFF condition within the same experimental session) |
| de Freitas RM, Capogrosso M, Nomura T, Milosevic M. Preferential activation of proprioceptive and cutaneous sensory fibers compared to motor fibers during cervical transcutaneous spinal cord stimulation: a computational study. J Neural Eng. 2022 May 17;19(3). doi: 10.1088/1741-2552/ac6a7c. |
| 33400652 | Background | Inanici F, Brighton LN, Samejima S, Hofstetter CP, Moritz CT. Transcutaneous Spinal Cord Stimulation Restores Hand and Arm Function After Spinal Cord Injury. IEEE Trans Neural Syst Rehabil Eng. 2021;29:310-319. doi: 10.1109/TNSRE.2021.3049133. Epub 2021 Mar 2. |
| 38769431 | Background | Moritz C, Field-Fote EC, Tefertiller C, van Nes I, Trumbower R, Kalsi-Ryan S, Purcell M, Janssen TWJ, Krassioukov A, Morse LR, Zhao KD, Guest J, Marino RJ, Murray LM, Wecht JM, Rieger M, Pradarelli J, Turner A, D'Amico J, Squair JW, Courtine G. Non-invasive spinal cord electrical stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial. Nat Med. 2024 May;30(5):1276-1283. doi: 10.1038/s41591-024-02940-9. Epub 2024 May 20. |
| 36807682 | Background | Powell MP, Verma N, Sorensen E, Carranza E, Boos A, Fields DP, Roy S, Ensel S, Barra B, Balzer J, Goldsmith J, Friedlander RM, Wittenberg GF, Fisher LE, Krakauer JW, Gerszten PC, Pirondini E, Weber DJ, Capogrosso M. Epidural stimulation of the cervical spinal cord for post-stroke upper-limb paresis. Nat Med. 2023 Mar;29(3):689-699. doi: 10.1038/s41591-022-02202-6. Epub 2023 Feb 20. |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |