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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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
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
- 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.
- 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.
- 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.
- 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.
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
|United States, California|
|Palo Alto, California, United States, 94304|