| NCT ID | NCT05553353 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-03-31 |
| Primary Completion | 2027-04-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 24 participants in total. It began in 2025-03-31 with a primary completion date of 2027-04-15.
⚠ 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 a leading cause of disability worldwide and is more commonly seen in individual's post-spinal cord injury (SCI) than in the general population. Depression post-SCI impacts an individuals' quality of life and recovery. It has been reported that among Veterans with an SCI, those without depression live longer than those with depression. Thus, depression must be treated appropriately. Repetitive transcranial magnetic stimulation (rTMS) is an FDA-approved treatment for depression, but dosing is based on a motor response or movement in the thumb. Over half of individuals with SCI have some degree of arm or hand impairment, so these individuals might not be eligible for rTMS, or they may receive the wrong dose. This study proposes clinical trial in individuals with depression post-SCI to assess the anti-depressant effect of a novel technique to dose rTMS that does not require a motor response in the thumb. By gaining a better understanding of the application of rTMS for depression post-SCI, the investigators aim to advance the rehabilitative care of Veterans.
Eligibility Criteria
Inclusion Criteria: * cervical or thoracic spinal cord injury at least 6 months prior with AIS A, B, C, or D; * 18 - 60 years of age; * major depressive disorder, as identified by Structured Clinical Interview for DSM-V; * Hamilton Depression Rating Scale-17 score \> 18; * not taking antidepressant medications or no change in doses of psychotropic medication(s) for at least 4 weeks before the study (6 weeks if newly initiated medication) Exclusion Criteria: * concomitant neurologic diseases/disorders or dementia; * cognitive impairment (Montreal Cognitive Assessment \<17); * history of psychosis or other Axis I disorder that is primary; * positive screen for bipolar disorder through the Mini-International Neuropsychiatric Interview; * history of claustrophobia; * life expectancy \<1 year; * electronic or metallic implants (i.e., metal in the head, cochlear implant, or pacemaker; * history of seizures or currently prescribed anti-seizure medications; * taking medication that increases the risk of seizures; * pregnancy as identified through a positive urine pregnancy test; * Hamilton Depression Rating Scale-17 question #3 regarding suicide: \>2 or suicide attempt within the previous two years; * inability to (University of California, San Diego Brief Assessment of Capacity to Consent) or declined to give informed consent.
Contact & Investigator
Catherine J VanDerwerker, PhD DPT PT
PRINCIPAL INVESTIGATOR
Ralph H. Johnson VA Medical Center, Charleston, SC
Frequently Asked Questions
Who can join the NCT05553353 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, 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 NCT05553353 currently recruiting?
Yes, NCT05553353 is actively recruiting participants. Contact the research team at catherine.vanderwerker@va.gov for enrollment information.
Where is the NCT05553353 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT05553353 clinical trial?
NCT05553353 is sponsored by VA Office of Research and Development. The principal investigator is Catherine J VanDerwerker, PhD DPT PT at Ralph H. Johnson VA Medical Center, Charleston, SC. The trial plans to enroll 24 participants.