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Brain Imaging of rTMS Treatment for Depression

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ClinicalTrials.gov Identifier: NCT01829165
Recruitment Status : Completed
First Posted : April 11, 2013
Results First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Collaborators:
The Dana Foundation
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Amit Etkin, 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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Depression Device: rTMS Treatment Device: Sham rTMS Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Causal Neural Network-level Understanding of Depression and Its Treatment Through Concurrent TMS and fMRI
Study Start Date : September 2012
Actual Primary Completion Date : January 20, 2017
Actual Study Completion Date : January 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: rTMS Treatment
rTMS will be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS will be delivered using neuro-navigation based on participants' own fMRI images. Daily treatment regiments will last 36.5 minutes and rTMS will be delivered at 120% of the participant's motor threshold. Participants will be monitored during the rTMS sessions for adverse events and/or side effects.
Device: rTMS Treatment
MRI-compatible TMS stimulator
Other Names:
  • Magstim Stimulator
  • Magventure Stimulator

Sham Comparator: Sham Treatment

rTMS will be delivered for 20 sessions over 4 weeks. Placebo 10Hz rTMS will be delivered through sham stimulation electrodes. The rTMS coil will be positioned using neuro-navigation based on participants' own fMRI images, mimicking active rTMS treatment. Daily treatment regiments will last 36.5minutes and sham rTMS will be delivered at 120% of the participant's motor threshold. Participants will be monitored during the rTMS sham sessions for adverse events and/or side effects.

Upon completing the sham 20 sessions participants are unblinded and offered 20 further treatments of guaranteed open-label treatment. The open-label treatment would follow the active rTMS treatment protocol.

Device: Sham rTMS Treatment



Primary Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829165


Locations
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United States, California
Stanford University
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
The Dana Foundation
National Institute of Mental Health (NIMH)
  Study Documents (Full-Text)

Documents provided by Amit Etkin, Stanford University:

Additional Information:
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Responsible Party: Amit Etkin, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01829165     History of Changes
Other Study ID Numbers: 21206
P30MH089888-01 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2013    Key Record Dates
Results First Posted: April 10, 2018
Last Update Posted: April 10, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders