NCT06989905 MEP Up-conditioning to Target Corticospinal Plasticity
| NCT ID | NCT06989905 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Medical University of South Carolina |
| Condition | Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 11 participants |
| Start Date | 2025-05-27 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 11 participants in total. It began in 2025-05-27 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Allison Lewis, DPT, PhD
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT06989905 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06989905 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06989905 currently recruiting?
Yes, NCT06989905 is actively recruiting participants. Contact the research team at stecb@musc.edu for enrollment information.
Where is the NCT06989905 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT06989905 clinical trial?
NCT06989905 is sponsored by Medical University of South Carolina. The principal investigator is Allison Lewis, DPT, PhD at Medical University of South Carolina. The trial plans to enroll 11 participants.