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Dosing rTMS for Depression Post-SCI

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Over four years, twenty-four individual post-SCI with MDD will be enrolled and randomized to receive 6 weeks (5 sessions/week) of either active or sham rTMS treatment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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.

Study sites (1)

SC