Brain Imaging of rTMS Treatment for Depression
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829165
|United States, California|
|Palo Alto, California, United States, 94304|