Motoneuron Recruitment and Motor Evoked Potential Up-Conditioning (MEP) in Spinal Cord Injury (SCI)

NCT07179822 | Recruiting DMC

• 2 other identifiers: Pro001455811R21HD118383
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Movement Disorders; Rehabilitation Studies

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

Study Arms (1)

Motor Evoked Potential (MEP) Operant Conditioning

EXPERIMENTAL

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

Interventions

Motor Evoked Potential (MEP) Operant Conditioning BEHAVIORAL

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.

Motor Evoked Potential (MEP) Operant Conditioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Northwestern University: collaborator
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29407, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Disease; Movement Disorders

Interventions

Evoked Potentials, Motor

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Aiko Thompson, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Occupational Therapist

CONTACT

(843) 792-6313; stecb@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Faculty

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 18, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)