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N/A N=33 Randomized Double-blind Treatment

Brain Imaging of rTMS Treatment for Depression

Major Depressive Disorder · Depression

Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Clinician Administered HAM-D — 27.0; 26.2; 22.0; 22.7 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
rTMS Treatment (Device); Sham rTMS Treatment (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Stanford University
Primary completion
Jan 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Clinician Administered HAM-D
27.0; 26.2; 22.0; 22.7; 17.9; 17.6

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01829165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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