Cervical Transcutaneous SCS for TBI

Not Applicable

Not yet recruiting

• Conditions: Traumatic Brain Injury; TBI (Traumatic Brain Injury)

• Registration Number: NCT07147816
• Lead Sponsor: Roberto de Freitas

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.

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 Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-20
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-08-29
• Last Update Posted: 2025-08-29
• Study Start: 2025-11-01
• Primary Completion: 2029-11-01
• Study Completion: 2029-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Strength	Immediate (tSCS ON vs tSCS OFF condition within the same experimental session)	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.

Secondary Outcome Measures

Name	Time	Method
Spasticity	Immediate (tSCS ON vs tSCS OFF condition within the same experimental session)	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.
Movement smoothness	Immediate (tSCS ON vs tSCS OFF condition within the same experimental session)	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.
Joint velocity	Immediate (tSCS ON vs tSCS OFF condition within the same experimental session)	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.
Discomfort/Pain	Immediate (while tSCS is ON)	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.
Join Synergies	Immediate (tSCS ON vs tSCS OFF condition within the same experimental session)	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.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States