NCT07147816

Cervical Transcutaneous SCS for TBI

Effects of Transcutaneous Cervical Spinal Cord Stimulation on Upper Limb Motor Function After Traumatic Brain Injury

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Roberto de Freitas · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Traumatic Brain Injury
• TBI (Traumatic Brain Injury)

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-11-26
• Primary completion: 2026-01-29
• Completion: 2026-01-29
• First posted: 2025-08-29
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study