| NCT ID | NCT04263285 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of South Carolina |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2026-10 |
| Primary Completion | 2029-09 |
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 14 participants in total. It began in 2026-10 with a primary completion date of 2029-09.
⚠ 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
Depression is more common after a spinal cord injury (SCI) than in the general population. Unfortunately, it is unknown how depression is typically treated in individuals with SCI or if commonly used treatment methods are effective. This study will investigate the safety and impact of a novel method for treating depression called repetitive transcranial magnetic stimulation (rTMS). rTMS is a type of non-invasive brain stimulation. Fourteen individuals with a cervical or thoracic level SCI and depression will complete an approved treatment plan using rTMS. Participants will be treated using rTMS five days a week for four weeks. After four weeks of treatment, the study team will review the safety of rTMS and assess changes in depressive symptoms. If the results are positive, larger studies can be designed to develop better treatment options for individuals with SCI and depression.
Eligibility Criteria
Inclusion criteria: 1. Age 18 - 70; 2. At least 6 months post incomplete cervical or incomplete or complete thoracic level SCI; 3. Have at least partial active movement of the right thumb (abductor pollicis brevis) to allow for FDA approved rTMS dosing; 4. Major depressive disorder, as identified through screening tools; 5. No antidepressant medications or no change in doses of psychotropic medication(s) for at least 4 weeks prior to the study (6 weeks if newly initiated medication). Exclusion criteria: 1. Concomitant neurologic diseases/disorders or dementia; 2. Cognitive impairment, as identified through a screening tool (Montreal Cognitive Assessment); 3. History of major head trauma as identified through a screening tool (Ohio State University Traumatic Brain Injury Identification Method); 4. History of psychosis or other Axis I disorder that is primary; 5. Positive screen for bipolar disorder, as identified through a screening tool (The Mood Disorder Questionnaire); 6. Life expectancy \<1 year; 7. Attempt of suicide in the last 2 years; 8. Electronic or metallic implants (i.e. metal in the head, cochlear implant, or pacemaker); 9. History of seizures or currently prescribed anti-seizure medications; 10. Taking medication that increases the risk of seizures; 11. Pregnancy as identified through a positive pregnancy test; 12. Inability or unwillingness of subject or legal guardian/representative to give informed consent.
Contact & Investigator
Catherine VanDerwerker, DPT, PhD
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT04263285 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04263285 currently recruiting?
Yes, NCT04263285 is actively recruiting participants. Contact the research team at vanderwe@musc.edu for enrollment information.
Where is the NCT04263285 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT04263285 clinical trial?
NCT04263285 is sponsored by Medical University of South Carolina. The principal investigator is Catherine VanDerwerker, DPT, PhD at Medical University of South Carolina. The trial plans to enroll 14 participants.
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