fMRI-neuronavigated Repetitive Transcranial Magnetic Stimulation for the Treatment of Major Depression Associated With Traumatic Brain Injury
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Major Depressive Disorder
- Sponsor
- Washington University School of Medicine
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Improvement in depressive symptoms
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
This pilot study aims to investigate the efficacy of fMRI-targeted repetitive transcranial magnetic stimulation (rTMS) in treatment of major depression associated with traumatic brain injury (TBI). Half of patients will receive active treatment, while the other will receive a sham treatment with the option of receiving open-label active treatment afterwards.
Detailed Description
rTMS is an FDA-approved treatment for major depressive disorder, but its utility has not yet been investigated for major depression associated with traumatic brain injury. This will be a prospective double-blind randomized sham-controlled crossover study. Patients in the treatment group will receive 20 sessions of high-frequency rTMS over the left dorsolateral prefrontal cortex (DLPFC) and low-frequency rTMS over the right DLPFC. The DLPFC will be identified as target by using individual subject-level resting state network estimation (Hacker et al, 2013). Patients in the control group will receive 20 sham treatments designed to be visibly indistinguishable from active treatment, and will subsequently have the option to be crossed over to receive active treatment with the aforementioned protocol. A subgroup of patients in each group will receive more detailed diffusion imaging (diffusion tensor and diffusion kurtosis imaging) and resting state fMRI scans before and after the treatment in order to assess for changes in white matter integrity and functional connectivity associated with the treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Improvement in depressive symptoms
Time Frame: Difference between pre-treatment (baseline) and post-treatment (4 weeks)
This will be measured as the mean percentage change in baseline scores on Montgomery-Asberg Depression Rating Scale (MADRS) before treatment and immediately after the 4-week treatment period.
Secondary Outcomes
- Changes in headache scales(Difference between pre-treatment (baseline) and post-treatment (4 weeks))
- Changes in resting-state fMRI and DTI findings(Difference between pre-treatment (baseline) and post-treatment (4 weeks))
- Response and remission rates in depressive symptoms(Difference between pre-treatment (baseline) and post-treatment (4 weeks))
- Changes in tinnitus score(Difference between pre-treatment (baseline) and post-treatment (4 weeks))
- Changes in NIH Toolbox Cognitive, Emotional, and Quality of Life batteries(Difference between pre-treatment (baseline) and post-treatment (4 weeks))
- Changes in temperament and character(Difference between pre-treatment (baseline) and post-treatment (4 weeks))