Recruiting

TMS

Sponsor:

Medical University of South Carolina

Code:

NCT07179822

Conditions

Spinal Cord Injuries and Disorders (SCI/D)

Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Motor Evoked Potential (MEP) Operant Conditioning

Study Details

Brief summary:

The purpose of this research study is to examine the effect of a brain stimulation training to improve the function of brain-spinal cord- muscle connections. Because brain-to-muscle pathways are very important in our movement control, restoring function of these pathways may improve movement problems after injuries. Spinal cord injury causes damage to the brain-to-muscle connection. However, when the injury is "incomplete", there is a possibility that some of the brain-to-muscle pathways are still connected and may be trained to improve movement function. For examining brain-to-muscle pathways, investigators use a transcranial magnetic stimulator. Investigators hope that the results of this research study will help us develop new treatments for people who have movement disabilities. This study will require about 42 visits over the first 14 weeks, and another 6 visits over an additional 3 months. Each visit will take about 1 ½ hours.

Conditions

Spinal Cord Injuries and Disorders (SCI/D)

Spinal Cord Injury

Study ID

NCT07179822

Start date

Nov 3, 2025

Status verified date

Jul, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult (≥18 yrs old)
  • a history of injury to spinal cord at or above C6
  • neurologically stable (>1 year post SCI)
  • medical clearance to participate
  • weak wrist extension at least unilaterally
  • expectation that current medication will be maintained without change for at least 3 months.

  • Stable use of anti-spasticity medication (e.g., baclofen, diazepam, tizanidine) is accepted. (Because only neurologically stable subjects will enter this study, medication changes will be unlikely.)
  • In participants with bilateral wrist extension weakness in whom Extensor Carpi Radialis (ECR) MEP can be elicited in both arms, the more severely impaired arm is studied. In participants with unilateral wrist weakness or in participants with bilateral wrist weakness in whom an ECR MEP can be elicited in only one arm, that arm is studied.

Exclusion Criteria:

  • motoneuron injury
  • unstable medical condition
  • cognitive impairment (because the studied intervention is a learning-based intervention)
  • a history of epileptic seizures
  • a pre-existing or confounding neurological condition (e.g., history of MS, Stroke, Parkinson's disease)
  • metal implants in the cranium
  • implanted biomedical device in or above the chest (e.g., a cardiac pacemaker, cochlear implant)
  • no measurable MEP elicited in the ECR
  • inability to produce any voluntary ECR EMG activity
  • extensive use of functional electrical stimulation to the arm on a daily basis (as it may interfere with or augment the effects of MEP conditioning itself)
  • pregnancy (due to changes in posture and potential medical instability)
  • inability or unwillingness of subject or legal guardian/representative to give informed consent

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Motor Evoked Potential (MEP) Operant Conditioning

This intervention requires 6 baseline visits and 24 intervention visits, each of which is approximately 1.5 hours.

Interventions

Motor Evoked Potential (MEP) Operant Conditioning

Operant conditioning is a method to induce behavioral learning based on the consequence (reward) of the behavior. With operant conditioning of the motor evoked potential (MEP), the neuronal excitability and behavior of the corticospinal pathway that involves production of MEP is targeted and trained (i.e., up-trained with up-conditioning). The individual is rewarded only for changing the target muscle's MEP size without changing background muscle activity. Since MEP size reflects the corticospinal excitability at or just before the time of stimulation, during MEP up-conditioning trials, the individual is urged to increase the corticospinal excitability for the target muscle.

Primary outcome measure

  • Percent change in the size of the Motor Evoked Potential (MEP) from baseline to final conditioning sessions. [ Time Frame: Baseline (average of 6 sessions over 2 weeks) and final phase (average of sessions 19-24 over weeks 7-8 of intervention) ]
  • Change in Spinal Cord Independence Measure--version III (SCIM III) score [ Time Frame: Baseline (Week 0), mid-intervention (Week 5, after session 12), post-intervention (Week 9, after session 24), and follow-up at 1 month (Week 13) and 3 months (Week 21) post-intervention. ]

Central Contacts and Locations

Central contacts

Occupational Therapist

(843) 792-6313stecb@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29407

Contacts

Blair Dellenbach, MSOT

843-792-6313stecb@musc.edu

Principal Investigator:

Aiko Thompson, PhD

More Information

Sponsor

Medical University of South Carolina

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • Movement Disorders
  • Rehabilitation Studies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-07-29.