Cervical Transcutaneous SCS for TBI

NCT07147816 | Terminated FDA Device

• 1 other identifier: STUDY25060159
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Traumatic Brain Injury; TBI (Traumatic Brain Injury)

Keywords

Spinal Cord Stimulation; Transcutaneous Spinal Cord Stimulation; SCS; tSCS

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• Spasticity

  Immediate (tSCS ON vs tSCS OFF condition within the same experimental session)

• Movement smoothness

  Immediate (tSCS ON vs tSCS OFF condition within the same experimental session)

• Joint velocity

  Immediate (tSCS ON vs tSCS OFF condition within the same experimental session)

• Discomfort/Pain

  Immediate (while tSCS is ON)

• Join Synergies

  Immediate (tSCS ON vs tSCS OFF condition within the same experimental session)

Study Arms (1)

Transcutaneous electrical stimulation of the cervical spinal cord (tSCS)

EXPERIMENTAL

Device: Transcutaneous electrical stimulation of the cervical spinal cord (tSCS)

Interventions

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.

Transcutaneous electrical stimulation of the cervical spinal cord (tSCS)

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Roberto de Freitas: lead
• Chuck Noll Foundation: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (5)

• 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.

  PMID: 34138648 BACKGROUND

• 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.

  PMID: 35472720 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.

  PMID: 33400652 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.

  PMID: 38769431 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.

  PMID: 36807682 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Roberto M de Freitas, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, non-randomized, open-label, descriptive, experimental study.

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 29, 2025
• Study Start: November 26, 2025
• Primary Completion: January 29, 2026
• Study Completion: January 29, 2026
• Last Updated: February 9, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)