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Completed

NCT Number: NCT01829165

Brain Imaging of rTMS Treatment for Depression

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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rTMS treatment

Device

MRI-compatible TMS stimulator

Other names: Magstim Stimulator, Magventure Stimulator

Sham rTMS Treatment

Device

Primary outcomes

  1. Clinician Administered HAM-D

    Time frame: Baseline; 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.

Other outcomes

  1. fMRI/TMS Assessed Neural Network Connectivity

    Time frame: Up to 3 months.

    From pre- to post-treatment, improvement will be based on enhanced functional connectivity.

  2. Implicit Emotion Regulation

    Time frame: Up to 3 months

    Implicit emotion regulation assessed through emotion conflict task performed during functional imaging. Performance based on reaction time and recruitment of emotion regulation regions during the task.

  3. fMRI-assessed Resting Connectivity

    Time frame: Up to 3 months.

    From pre- to post-treatment of patients with high-frequency repetitive TMS (rTMS) improvement shall be measured by normalization of baseline network-level deficits.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • The Dana Foundation

Registry information

Official study title

A Causal Neural Network-level Understanding of Depression and Its Treatment Through Concurrent TMS and fMRI

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Apr 11, 2013
Registry last updated
Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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