NCT07179822 · Medical University of South Carolina
Motoneuron Recruitment and Motor Evoked Potential Up-Conditioning (MEP) in Spinal Cord Injury (SCI)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
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)
MEP from each session is expressed as the percent of the initial MEP size (average MEP size from the 6 baseline sessions). The final MEP size is the fitted estimate of the MEP size at the end of 24 intervention sessions. MEP size is a measurement of the integrity of the corticospinal tract.
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.
To measure basic functional independence, we will use the most recent version of the SCIM (SCIM III), which is self-reported and comprises 19 items in three sub-scales: (1) self-care (6 items, subscore 0-20); (2) respiration and sphincter management (4 items, sub-score 0-40); and (3) mobility (9 items, subscore 0-40). The total score ranges from 0-100. The items are weighted in terms of their presumed clinical relevance. SCIM score will be used for calculation of MCID.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Charleston, South Carolina
Collaborators
Northwestern University, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 29, 2026 · Source of record for eligibility and locations