Using rTMS to Treat Depression in Veterans with Spinal Cord Injuries

Evaluating a Novel Method to Determine the rTMS Dose Needed for Treating Depression After Spinal Cord Injury

This study is testing a new way to use brain stimulation to help veterans with spinal cord injuries who are struggling with depression.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: VA Office of Research and Development (Federal)
• Locations: 1 site (Charleston, South Carolina)
• Trial ID: NCT05553353 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of repetitive transcranial magnetic stimulation (rTMS) as a treatment for major depressive disorder in individuals who have experienced spinal cord injuries (SCI). The study aims to develop a novel dosing technique for rTMS that does not rely on motor responses, which is crucial since many SCI patients have upper extremity impairments. By focusing on this specific population, the trial seeks to improve treatment accessibility and effectiveness for those suffering from depression post-SCI. The study will assess the antidepressant effects of rTMS in eligible participants over a defined period.

Who should consider this trial

Good fit: Ideal candidates for this study are veterans with cervical or thoracic spinal cord injuries who have been diagnosed with major depressive disorder.

Not a fit: Patients with concomitant neurological disorders, cognitive impairments, or those currently on antidepressant medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective treatment option for depression in veterans with spinal cord injuries, improving their quality of life and recovery outcomes.

How similar studies have performed: While rTMS has been shown to be effective for depression in general populations, this specific application for veterans with spinal cord injuries is novel and has not been extensively tested.

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.

Where this trial is running

Charleston, South Carolina

• Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston, South Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Catherine J VanDerwerker, PhD DPT PT — Ralph H. Johnson VA Medical Center, Charleston, SC
• Study coordinator: Catherine J VanDerwerker, PhD DPT PT

Conditions Spinal Cord Injuries; Depression; Depressive Disorder, Major; Transcranial Magnetic Stimulation