NCT05321017 Wrist Extensor MEP Up-conditioning for Individuals With Incomplete Spinal Cord Injury
| NCT ID | NCT05321017 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of South Carolina |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2021-10-12 |
| Primary Completion | 2026-06-30 |
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.
This trial targets 5 participants in total. It began in 2021-10-12 with a primary completion date of 2026-06-30.
⚠ 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
The purpose of this study is to examine the relationship between common clinical assessments and measurements of the function of brain-spinal cord-muscle connections, and to examine the effects of training a brain-spinal cord-muscle response in individuals with incomplete spinal cord injury. A transcranial magnetic stimulator (TMS) is used for examining brain-to-muscle pathways. This stimulator produces a magnetic field for a very short period of time and indirectly stimulates brain cells with little or no discomfort. The target muscle is the wrist extensor (extensor carpi radialis) muscle that bends the wrist back. It is hypothesized that training the wrist extensor muscle response to transcranial magnetic stimulation will increase the strength of the brain-to-muscle pathway, which will improve the ability to move the arm. It is hoped that the results of this training study will help in developing therapy strategies for individuals, promoting better understanding of clinical assessments, and understanding treatments that aim to improve function recovery in people with spinal cord injury (SCI). This study requires 30 visits, and each visit will last approximately 1.5 hours.
Eligibility Criteria
Inclusion Criteria: 1. a history of injury to spinal cord at or above C6 2. neurologically stable (\>6 mo post SCI) 3. medical clearance to participate 4. weak wrist extension at least unilaterally 5. 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. In participants with bilateral wrist extension weakness, the more severely impaired arm is studied. Exclusion Criteria: 1. motoneuron injury 2. medically unstable condition 3. cognitive impairment 4. a history of epileptic seizures 5. metal implants in the cranium 6. implanted biomedical device in or above the chest (e.g., a cardiac pacemaker, cochlear implant) 7. no measurable MEP elicited in the ECR 8. unable to produce any voluntary ECR EMG activity 9. extensive use of functional electrical stimulation to the arm on a daily basis 10. pregnancy (due to changes in posture and potential medical instability).
Contact & Investigator
Blair Dellenbach, MSOT
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT05321017 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05321017 currently recruiting?
Yes, NCT05321017 is actively recruiting participants. Contact the research team at stecb@musc.edu for enrollment information.
Where is the NCT05321017 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT05321017 clinical trial?
NCT05321017 is sponsored by Medical University of South Carolina. The principal investigator is Blair Dellenbach, MSOT at Medical University of South Carolina. The trial plans to enroll 5 participants.