Dosing rTMS for Depression Post-SCI
Recruiting · NCT05553353 · Interventional (participants receive a specific treatment) · Lead sponsor: VA Office of Research and Development
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
1 location listed across 1 US state.
- Ralph H. Johnson VA Medical Center, Charleston, SC - Charleston, South Carolina, United States