Evaluating a Novel Method to Determine the rTMS Dose Needed for Treating Depression After Spinal Cord Injury
VA Office of Research and Development
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.
Description
Depression is a leading cause of disability worldwide and is one of the most prevalent neuropsychiatric manifestations following spinal cord injury (SCI). Based on an estimated 42,000 Veterans having an SCI1 and an estimated prevalence of depression among Veterans post-SCI of 19-28%, nearly 12,000 Veterans with SCI have comorbid depression at any time. The burden of depression post-SCI is significant, as it can impact quality of life and is associated with increased healthcare utilization and higher mortality. As noted by the updated Clinical Practice Guidelines from the Paralyzed Veterans of…
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- No
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 psyc…
Interventions
- Devicerepetitive transcranial magnetic stimulation--Active
Repetitive transcranial magnetic stimulation (rTMS) is a type of non-invasive brain stimulation. An active coil will be used to administer the active rTMS.
- Devicerepetitive transcranial magnetic stimulation--Sham
Repetitive transcranial magnetic stimulation (rTMS) is a type of non-invasive brain stimulation. A sham coil will be used to administer the sham rTMS.
Location
- Ralph H. Johnson VA Medical Center, Charleston, SCCharleston, South Carolina