MEP Up-conditioning to Target Corticospinal Plasticity

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT06989905
Phase
EARLY_PHASE1
Status
Recruiting

Conditions

  • Spinal Cord Injury
  • Tetraplegia/Tetraparesis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).

Study Details

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.

Key Dates

Start date
May 27, 2025
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
11 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Operant Up-Conditioning of the Motor Evoked Potential
    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).

Primary Outcome Measure

Extensor Carpi Radialis (ECR) Motor Evoked Potential (MEP) amplitude [ Time Frame: 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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
Allison Lewis, DPT, PhD
843-792-6313
Allison Lewis, DPT, PhD (PRINCIPAL_INVESTIGATOR)

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