Traumatic Brain InjuryNCT07147816
Cervical Transcutaneous SCS for TBI
A study testing Transcutaneous electrical stimulation of the cervical spinal cord (tSCS) in people with Traumatic Brain Injury and TBI (Traumatic Brain Injury), run by Roberto de Freitas at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, TBI (Traumatic Brain Injury)
- What is being tested?
- Transcutaneous electrical stimulation of the cervical spinal cord (tSCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2025to 29 Jan 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- TRAUMATIC BRAIN INJURY (TBI) SUBJECTS:
- Participants must have a suffered a traumatic brain injury resulting in impairments in arm and hand motor function at least one year prior to enrollment.
- Participants must be between the ages of 21 and 70 years old.
- HEALTHY CONTROL SUBJECTS:
- Participants must have full range of motion in their upper limbs;
- Participants must be between the ages of 21 and 70 years old.
Who cannot join
- TRAUMATIC BRAIN INJURY (TBI) SUBJECTS:
- Participants with severe behavioral or cognitive impairments (e.g., aphasia, apraxia, visual neglect) that could preclude their ability to participate in the study.
- Participants diagnosed with Paroxysmal Sympathetic Hyperactivity (PSH);
- Participants with post-TBI heterotopic ossification or tendon contractures that restricts passive range of motion of upper limb joints;
- Participants with uncontrolled epilepsy or untreated seizure disorders;
- Participants with implanted electronic devices, such as pacemakers and spinal cord stimulators;
Show all 12Show fewer
- Participants taking benzodiazepine for spasticity;
- Participants with serious disease or disorder (ex. neurological condition other than TBI, cancer, severe cardiac or respiratory disease, renal failure, etc.) that could affect their ability to participate in this study.
- Female participants must not be pregnant or breast feeding.
- Evaluation to sign consent form score <12.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Effects of Transcutaneous Cervical Spinal Cord Stimulation on Upper Limb Motor Function After Traumatic Brain Injury
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.
Read the detailed description
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.
- Being tested
- Transcutaneous electrical stimulation of the cervical spinal cord (tSCS)
- Keywords
- Spinal Cord Stimulation, Transcutaneous Spinal Cord Stimulation, SCS, tSCS
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous electrical stimulation of the cervical spinal cord (tSCS) | Experimental | Not described Receives: Device: Transcutaneous electrical stimulation of the cervical spinal cord (tSCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength
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.
Measured: Immediately during tSCS ON and tSCS OFF conditions within a single experimental session
Secondary outcomes (5)
Movement Smoothness
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.
Measured: Immediately during tSCS ON and tSCS OFF conditions within a single experimental session
Joint Velocity
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.
Measured: Immediately during tSCS ON and tSCS OFF conditions within a single experimental session
Discomfort/Pain
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.
Measured: Immediately during tSCS ON condition within a single experimental session
Joint 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.
Measured: Immediately during tSCS ON and tSCS OFF conditions within a single experimental session
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.
Measured: Immediately during tSCS ON and tSCS OFF conditions within a single experimental session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start26 Nov 2025
- Primary completion29 Jan 2026
- Study completion29 Jan 2026
Why it stopped: The study was terminated due to administrative and logistical constraints following the Principal Investigator's transfer to another institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-randomized, open-label, descriptive, experimental study.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roberto de Freitas
- Sponsor type
- University, hospital or other
- Collaborators
- Chuck Noll Foundation
- Responsible party
- Sponsor-investigator, Roberto de Freitas, University of Pittsburgh
- Investigators
- Roberto M de Freitas, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147816
- Sponsor's protocol ID
- STUDY25060159
- Status last verified
- Jul 2026
- First submitted
- 20 Aug 2025
- Last updated
- 15 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data may be shared with other researchers for the purpose of data analysis and collaboration.
Publications
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.
PubMed 34138648de 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.
PubMed 35472720Inanici 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.
PubMed 33400652Moritz 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.
PubMed 38769431Powell 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.
PubMed 36807682
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Cervical Spinal Cord Stimulation on Upper Limb Motor Function After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT07147816
- Acronym / sponsor ID
- STUDY25060159
- Keywords
- Spinal Cord Stimulation, Transcutaneous Spinal Cord Stimulation, SCS, tSCS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to administrative and logistical constraints following the Principal Investigator's transfer to another institution.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Roberto de FreitasUniversity, hospital or other
- Collaborators
- Chuck Noll Foundation
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- 29 Jan 2026 (actual)
- Study completion
- 29 Jan 2026 (actual)
- First posted
- 29 Aug 2025 (actual)
- Results
- Posted 15 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-randomized, open-label, descriptive, experimental study.
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous electrical stimulation of the cervical spinal cord (tSCS) | Experimental | Device: Transcutaneous electrical stimulation of the cervical spinal cord (tSCS) |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must have a suffered a traumatic brain injury resulting in impairments in arm and hand motor function at least one year prior to enrollment.
- Participants must be between the ages of 21 and 70 years old.
- Participants must have full range of motion in their upper limbs;
- Participants must be between the ages of 21 and 70 years old.
Key exclusion criteria (12 listed)
- Participants with severe behavioral or cognitive impairments (e.g., aphasia, apraxia, visual neglect) that could preclude their ability to participate in the study.
- Participants diagnosed with Paroxysmal Sympathetic Hyperactivity (PSH);
- Participants with post-TBI heterotopic ossification or tendon contractures that restricts passive range of motion of upper limb joints;
- Participants with uncontrolled epilepsy or untreated seizure disorders;
- Participants with implanted electronic devices, such as pacemakers and spinal cord stimulators;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical stimulation of the cervical spinal cord (tSCS)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. | Device | Transcutaneous electrical stimulation of the cervical spinal cord (tSCS) |
Primary outcome
Strength
Time frame: Immediately during tSCS ON and tSCS OFF conditions within a single experimental session
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.
5 secondary outcomes
Movement Smoothness
Time frame: Immediately during tSCS ON and tSCS OFF conditions within a single experimental session
Joint Velocity
Time frame: Immediately during tSCS ON and tSCS OFF conditions within a single experimental session
Discomfort/Pain
Time frame: Immediately during tSCS ON condition within a single experimental session
Joint Synergies
Time frame: Immediately during tSCS ON and tSCS OFF conditions within a single experimental session
Spasticity
Time frame: Immediately during tSCS ON and tSCS OFF conditions within a single experimental session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34138648de 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.
- Background: PubMed 35472720de 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.
- Background: PubMed 33400652Inanici 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.
- Background: PubMed 38769431Moritz 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.
- Background: PubMed 36807682Powell 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.
- Individual participant dataSharing planned: Yes. Data may be shared with other researchers for the purpose of data analysis and collaboration.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto M de Freitas, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical stimulation of the cervical spinal cord (tSCS) in people with Traumatic Brain Injury and TBI (Traumatic Brain Injury), run by Roberto de Freitas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength (time frame: Immediately during tSCS ON and tSCS OFF conditions within a single experimental session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07147816, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.