MEP Up-conditioning to Target Corticospinal Plasticity

NCT06989905 | Recruiting Early Phase 1

• 2 other identifiers: Pro001388691K99HD117041
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals with chronic cervical spinal cord injury will complete a 10-week training protocol where participants receive non-invasive brain stimulation and feedback on the size of the corresponding muscle response (wrist extensor). Investigators will assess the impact of the brain stimulation training on 1) the brain-to-spinal cord-to-muscle connection and 2) motor functions of the arm and hand. Also, brain and spine magnetic resonance imaging will be collected before and after the training. The imaging measurements will tell investigators about how spinal damage, brain function, and brain structure relate to motor presentation and the response to the training.

Conditions

Spinal Cord Injury; Tetraplegia/Tetraparesis

Keywords

Central Nervous System; Nervous System; Rehabilitation Studies; Spinal Cord; spinal cord injury; upper extremity; upper limb; motor impairment; tetraplegia; quadriplegia

Outcome Measures

Primary Outcomes (1)

• Extensor Carpi Radialis (ECR) Motor Evoked Potential (MEP) amplitude

  Size of MEP elicited at the fixed stimulus intensity (e.g., \~ 10-15% maximum stimulator output) of transcranial magnetic stimulation (TMS) above motor threshold) (in %M wave maximum amplitude)

  Reported as an average of the 6 baseline sessions (over weeks 1-2) and average of the last 6 conditioning sessions (over weeks 8-10)

Secondary Outcomes (5)

• Maximum Voluntary Contraction - ECR

  Reported as an average of the 6 baseline sessions (over weeks 1-2) and average of the last 6 conditioning sessions (over weeks 8-10)

• Capabilities Upper Extremity Test (CUE-T)

  Baseline, after the 24th conditioning session (typically within 1 week), 1 month and 3 months post

• Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP)

  Baseline, after the 24th conditioning session (typically within 1 week), 1 month and 3 months post

• Spinal Cord Independence Measure (SCIM III)

  Baseline, after the 24th conditioning session (typically within 1 week), 1 month and 3 months post

• Life Situation Questionnaire Revised (LSQ-R)

  Baseline, after the 24th conditioning session (typically within 1 week), 1 month and 3 months post

Other Outcomes (8)

• ECR MEP recruitment curve

  Baseline, after the 24th conditioning session (typically within 1 week), 1 month and 3 months post

• Silent Period Duration

  Reported as an average of the 6 baseline sessions (over weeks 1-2) and average of the last 6 conditioning sessions (over weeks 8-10)

• Spine imaging - lesion overlap with lateral corticospinal tract (LCST) or motor tract damage

  Baseline

Study Arms (1)

Operant Up-Conditioning of the Motor Evoked Potential

EXPERIMENTAL

The intervention consists of approximately 6 baseline sessions and 24 conditioning sessions at a pace of 3 sessions/week, 1-2 hour duration, over 10 weeks. At the beginning of each session, electromyographic (EMG) recording and nerve stimulating electrodes are placed over the arm. In all sessions, motor evoked potentials (MEPs) will be measured while the sitting subject provides a pre-set level of background muscle EMG with joint angles fixed. In 225 control trials of each baseline sessions and the first 20 trials of conditioning sessions the subject will receive no feedback as to MEP size (i.e., control MEPs). In 225 conditioning trials of each conditioning session, the subject will be encouraged to increase the target muscle MEP, and will receive immediate feedback as to whether MEP size was above a criterion (i.e., whether the trial was a success).

Behavioral: Up-conditioning of the wrist extensor motor evoked potential

Interventions

Up-conditioning of the wrist extensor motor evoked potential BEHAVIORAL

At the beginning of each session, EMG recording and nerve stimulating electrodes are placed over the arm. In all sessions, MEPs will be measured while the sitting subject provides a pre-set level of background muscle EMG with joint angles fixed. In 225 control trials of each baseline sessions and the first 20 trials of conditioning sessions the subject will receive no feedback as to MEP size (i.e., control MEPs). In 225 conditioning trials of each conditioning session, the subject will be encouraged to increase the target muscle MEP, and will receive immediate feedback as to whether MEP size was above a criterion (i.e., whether the trial was a success).

Operant Up-Conditioning of the Motor Evoked Potential

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
• \>6 months post SCI
• 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.

You may not qualify if:

• Motoneuron injury
• Medically unstable condition
• Cognitive impairment
• A history of epileptic seizures
• Metal implants in the cranium
• Implanted biomedical device in or above the chest (e.g., a cardiac pacemaker, cochlear implant)
• Extensive use of functional electrical stimulation to the arm on a daily basis
• Pregnancy (due to changes in posture and potential medical instability)
• Contraindications to MRI
• No measurable MEP elicited in the ECR
• Unable to produce any voluntary ECR EMG activity

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Doscher Neurorehabilitation Research Program: 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, 29425, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia; Neurologic Manifestations

Condition Hierarchy (Ancestors)

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

Study Officials

• Allison Lewis, DPT, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Recruitment Contact

CONTACT

843-792-6313; stecb@musc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-doctoral Scholar, Principal Investigator

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 25, 2025
• Study Start: May 27, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Data on NICHD DASH is available via controlled access. The requester must provide details about the study, funding source, principal investigator, and the names and email addresses of the authorized representative or Institutional Business Official, as well as any affiliated personnel. Additionally, the submission must include the NICHD DASH Data Use Agreement and, if required by the requested study, IRB Approval for Data Request. The requesting institution must also maintain active Federalwide Assurance (FWA) status MRI data in OpenNEURO is open to the public. Participants can opt in or out of sharing MRI data.

Locations

US (1)