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Brain Imaging of rTMS Treatment for Depression

Not Applicable
Completed
Conditions
Major Depressive Disorder
Depression
Registration Number
NCT01829165
Lead Sponsor
Stanford University
Brief Summary

The overarching goal of this research program is to elucidate causal and directional neural network- level abnormalities in depression, and how they are modulated by an individually-tailored, circuit-directed intervention. By using concurrent TMS and fMRI, the investigators can overcome a major limitation of neuroimaging - the inability to demonstrate causality. The investigators' findings will serve as a platform for future studies wherein TMS treatment can be directly guided by the investigators' ability to image and causally manipulate specific neural networks.

Aim 1: To examine causal interactions between two major brain networks in depression.

Aim 2: To examine the impact of antidepressant TMS on causal network abnormalities in depression.

Hypothesis 1: Depressed subjects will show blunted responses, compared to healthy controls, in two targeted and interacting networks, using concurrent transcranial magnetic stimulation (TMS) and functional magnetic resonance imaging (fMRI).

Hypothesis 2: Treatment of patients with high-frequency repetitive TMS (rTMS) will result in normalization of baseline network-level deficits, and be predicted by degree of baseline network abnormalities.

Detailed Description

This study has a single primary outcome measure and other measures are exploratory. Previous versions of this study record incorrectly listed some exploratory outcome measures as secondary.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
85
Inclusion Criteria
  • Men and women, ages 18 to 50
  • Depression assessed through phone screen
  • Must comprehend English well to ensure adequate comprehension of the fMRI and TMS instructions, and of clinical scales
  • Has failed >1 previous adequate antidepressant medication trials
  • Right-handed
  • No current or history of neurological disorders
  • No seizure disorder or risk of seizures
Exclusion Criteria
  • Any contraindication to being scanned in the 3T scanners at the Lucas Center or CNI such as having a pacemaker or implanted device that has not been cleared for scanning at the Lucas Center or CNI
  • Any unstable medical condition, any significant CNS neurological condition such as stroke, seizure, tumor, hemorrhage, multiple sclerosis, etc
  • Current rTMS treatment or prior treatment failure with rTMS
  • Current electroconvulsive therapy (ECT) or prior treatment failure with ECT
  • Currently pregnant or breastfeeding

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Clinician Administered HAM-DBaseline; Day 10; Day 20

The Hamilton Depression Rating Scale (HAM-D) is a 24-item clinician-administered assessment utilized as a way of determining a patient's level of depression before, during, and after treatment. It takes approximately 15-20 minutes to complete the interview and score the results. Subscale scores are 0-2 (10 questions), 0-3 (2 questions), and 0-4 (12 questions). Subscales are totaled for an overall score (range 0 -76). For the overall score and all subscales, lower scores correspond to fewer symptoms, and higher scores correspond more symptoms.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Stanford University

🇺🇸

Palo Alto, California, United States

Stanford University
🇺🇸Palo Alto, California, United States
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