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| ID | Type | Description | Link |
|---|---|---|---|
| P30MH089888-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The Dana Foundation | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rTMS Treatment | Experimental | 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. |
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| Sham Treatment | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS Treatment | Device | MRI-compatible TMS stimulator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administered HAM-D | 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. | Baseline; Day 10; Day 20 |
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| Measure | Description | Time Frame |
|---|---|---|
| fMRI/TMS Assessed Neural Network Connectivity | From pre- to post-treatment, improvement will be based on enhanced functional connectivity. | Up to 3 months. |
| Implicit Emotion Regulation | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States |
85 participants were enrolled and 33 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | rTMS Treatment | Rapid transcranial magnetic stimulation (rTMS) was to be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS was delivered using neuro-navigation based on participants' own functional magnetic resonance imaging (fMRI) images. Daily treatment regiments were to last 36.5 minutes and rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sessions for adverse events and/or side effects. rTMS Treatment: MRI-compatible TMS stimulator |
| FG001 | Sham Treatment | Sham rTMS was to be delivered for 20 sessions over 4 weeks. Placebo 10Hz rTMS was delivered through sham stimulation electrodes. The rTMS coil was positioned using neuro-navigation based on participants' own fMRI images, mimicking active rTMS treatment. Daily treatment regiments were to 36.5minutes and sham rTMS was delivered at 120% of the participant's motor threshold. Participants were 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. rTMS Treatment: MRI-compatible TMS stimulator |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Randomized and treated
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| ID | Title | Description |
|---|---|---|
| BG000 | rTMS Treatment | rTMS was to be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS was delivered using neuro-navigation based on participants' own fMRI images. Daily treatment regiments were to last 36.5 minutes and rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sessions for adverse events and/or side effects. rTMS Treatment: MRI-compatible TMS stimulator |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinician Administered HAM-D | 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. | Randomized and treated | Posted | Mean | Standard Deviation | units on a scale | Baseline; Day 10; Day 20 |
|
Up to 9 months
Randomized and treated population
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | rTMS Treatment | rTMS was to be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS was delivered using neuro-navigation based on participants' own fMRI images. Daily treatment regiments were to last 36.5 minutes and rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sessions for adverse events and/or side effects. rTMS Treatment: MRI-compatible TMS stimulator |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Startled by rTMS device | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amit Etkin, MD, PhD | Stanford University | (650) 725-5736 | aetkin@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2018 | Jan 19, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| Sham rTMS Treatment | Device |
|
| Up to 3 months |
| fMRI-assessed Resting Connectivity | From pre- to post-treatment of patients with high-frequency repetitive TMS (rTMS) improvement shall be measured by normalization of baseline network-level deficits. | Up to 3 months. |
| BG001 | Sham Treatment | Sham rTMS was to be delivered for 20 sessions over 4 weeks. Placebo 10Hz rTMS was delivered through sham stimulation electrodes. The rTMS coil was positioned using neuro-navigation based on participants' own fMRI images, mimicking active rTMS treatment. Daily treatment regiments were to 36.5minutes and sham rTMS was delivered at 120% of the participant's motor threshold. Participants were 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. rTMS Treatment: MRI-compatible TMS stimulator |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Hamilton Depression Rating Scale (HAM-D 24) | 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. 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Sham Treatment | Sham rTMS was to be delivered for 20 sessions over 4 weeks. Placebo 10Hz rTMS was delivered through sham stimulation electrodes. The rTMS coil was positioned using neuro-navigation based on participants' own fMRI images, mimicking active rTMS treatment. Daily treatment regiments were to 36.5minutes and sham rTMS was delivered at 120% of the participant's motor threshold. Participants were 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. rTMS Treatment: MRI-compatible TMS stimulator |
|
|
| Other Pre-specified | fMRI/TMS Assessed Neural Network Connectivity | From pre- to post-treatment, improvement will be based on enhanced functional connectivity. | Not Posted | Up to 3 months. | Participants |
| Other Pre-specified | Implicit Emotion Regulation | 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. | Not Posted | Up to 3 months | Participants |
| Other Pre-specified | fMRI-assessed Resting Connectivity | From pre- to post-treatment of patients with high-frequency repetitive TMS (rTMS) improvement shall be measured by normalization of baseline network-level deficits. | Not Posted | Up to 3 months. | Participants |
| 0 |
| 20 |
| 0 |
| 20 |
| 1 |
| 20 |
| EG001 | Sham Treatment | Sham rTMS was to be delivered for 20 sessions over 4 weeks. Placebo 10Hz rTMS was delivered through sham stimulation electrodes. The rTMS coil was positioned using neuro-navigation based on participants' own fMRI images, mimicking active rTMS treatment. Daily treatment regiments were to 36.5minutes and sham rTMS was delivered at 120% of the participant's motor threshold. Participants were 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. rTMS Treatment: MRI-compatible TMS stimulator | 0 | 13 | 0 | 13 | 1 | 13 |
| Abdominal Cramping Pain | General disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
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| D001519 |
| Behavior |