An interventional study of Motor Evoked Potential (MEP) Operant Conditioning in Spinal Cord Injuries and Disorders (SCI/D) and Spinal Cord Injury, sponsored by Medical University of South Carolina. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Basic science
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.
Regaining arm/hand function is one of the top priorities of individuals with tetraplegia and is a challenging problem, partly due to the complex nature of upper limb motor function. Through mass practice and conventional therapy, functions can be restored partially, likely through compensation rather than induction of relevant corticospinal plasticity. In such cases, corticospinal recruitment of motoneurons and resulting muscle activation could remain impaired and continue to limit function recovery. In people with incomplete SCI, voluntary activation of the muscles below the injury level is often diminished, due at least partly to impaired motor unit behaviors. Abnormal motoneuron recruitment and motor unit firing, also found in other CNS disorders, would certainly hinder effective production of motor functions. Thus, to enhance upper limb motor rehabilitation beyond what conventional therapy has been able to achieve, a method to improve corticospinal recruitment of a targeted pool of motoneurons would be needed. Here, investigators hypothesize that wrist extensor MEP up-conditioning can improve forearm motor functions in people with cervical SCI by increasing the corticospinal excitability and improving corticospinal recruitment of wrist extensor motoneurons.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 15 is below the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
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expectation that current medication will be maintained without change for at least 3 months.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This intervention requires 6 baseline visits and 24 intervention visits, each of which is approximately 1.5 hours.
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.
Percent change in the size of the Motor Evoked Potential (MEP) from baseline to final conditioning sessions.
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.
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
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.
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.
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Started Nov 2025 (actual). Primary completion is estimated for Sep 2027, 22 months after the start.
Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 22 months is below that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
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Medical University of South Carolina →