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Transcranial magnetic stimulation (TMS) is a noninvasive brain stimulation technique, its approved therapeutic indication is high-frequency stimulation to the left dorsolateral prefrontal cortex (DLPFC) for treatment resistant.
investigators design a prospective three-year study to exam the effect of TBS on reducing suicidality targeted at left DLPFC vs VLPFC, and guided by task fMRI neuronavigation and sham. Investigators will adopt personalized left DLPFC and VLPFC localization from baseline task fMRI data. Due to the global brain atrophic changes in the older adults, this issue has been even more important. Investigators will enroll 163 late life depression cases, they will be randomly allocated to either DLPFC group (65 cases), or VLPFC group (65 cases) and sham group (33 cases). To sum up, investigators seek to evaluate the impact of an acute course of TBS guided by tsked fMRI neuronavigation on suicidal ideation, and through follow-up for 6 months, investigators expect to examine (1) suicidal ideation, structural and functional brain differences, inflammatory markers pre/post TBS treatment, explore the link between the mechanism underlying of TBS on brain connectivity and therapeutic effects (2) Association of suicide ideation and neurocognitive function, inflammatory factors and brain imaging data. Exploratory analysis will assess suicide ideation as mediator in the association of neurocognitive deficit and functional connectivity or neurocognitive deficit as mediator in the association of suicide ideation and brain imaging data (3) The trajectories of suicidal ideation in late life depression, to analysis whether the association of cognitive dysfunction and suicidal ideation occurs across time and the prediction of neurocognitive function.(4) Explore the association of suicidal ideation the depression severity, to test if suicidal ideation could be an independent treatment target (5) Investigate the plausible predictors of neuropsychological profiles or neuroimaging findings associated to the effect of TBS in reducing suicidal ideation, which could provide a more efficient strategy for suicide prevention in the elder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dorsolateral prefrontal cortex | Experimental |
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| ventrolateral prefrontal cortex | Experimental |
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| sham comparator | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial magnetic stimulation | Device | Transcranial magnetic stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Beck Scale for Suicide Ideation (BSSI) at baseline | the severity of suicide ideation(the score range from 0-38,the higher score indicates higher severity. | baseline(1 week before treatment) |
| Beck Scale for Suicide Ideation (BSSI)at the 1st month | the severity of suicide ideation(the score range from 0-38,the higher score indicates higher severity) | the 1st month (4 weeks after baseline) |
| Beck Scale for Suicide Ideation (BSSI)at the 3rd month | the severity of suicide ideation(the score range from 0-38,the higher score indicates higher severity) | the 3rd month(12 weeks after baseline) |
| Beck Scale for Suicide Ideation (BSSI)at the 6th month | the severity of suicide ideation(the score range from 0-38,the higher score indicates higher severity) | the 6th month(24 weeks after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Geriatric Depression Scale | the severity of depression(the score range from 0-15,the higher score means worse outcome) | baseline(1 week before treatment), the 1st month(4 weeks after baseline), the 3rd moth(12 weeks after baseline), and the 6th month(24 weeks after baseline) |
| structural and functional connectivity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shwu-Hua Lee | Contact | 03-3281200 | 3839 | shlee@cgmh.org.tw |
| hsueh-ching tsai, bachelor | Contact | 03-3281200 | 3839 | stacy.tsai409@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shwu-Hua Lee | ChungGung memorial hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "MAGSTIM" Repetitive transcranial magnetic stimulator(rTMS) System | Recruiting | Taoyuan | Guishan | 333423 | Taiwan |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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Brain MRI connectivity change |
| baseline(1 week before treatment), the 1st month(4 weeks after baseline) |
| MRI T1 | Brain structural volumes (cm) | baseline(1 week before treatment), the 1st month(4 weeks after baseline) |
| functional MRI (resting-state/biological motion task) - BOLD signal | Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI which reflects the neural activity. | baseline(1 week before treatment), the 1st month(4 weeks after baseline) |
| Diffusion Tensor Imaging (DTI) - FA | Fractional anisotropy (FA) is a measurement used in DTI, which reflects the movement of water molecules. FA ranges from 0 to 1, the higher FA value may represent more intact axons.reflects the neural activity. | baseline(1 week before treatment), the 1st month(4 weeks after baseline) |
| Verbal Learning & Memory: | Word list of Wechsler Memory Scale-III Face memory task | baseline(1 week before treatment), the 1st month(4 weeks after baseline) and the 6th month(24 weeks after baseline) |
| Interleukin-1 | IL-1 | baseline(1 week before treatment), the 1st month(4 weeks after baseline) |
| Interleukin-2 | IL-2 | baseline(1 week before treatment), the 1st month(4 weeks after baseline) |
| Interleukin-6 | IL-6 | baseline(1 week before treatment), the 1st month(4 weeks after baseline) |
| Interleukin-10 | IL-10 | baseline(1 week before treatment), the 1st month(4 weeks after baseline) |
| Tumor necrosis factor | TNF-α | baseline(1 week before treatment), the 1st month(4 weeks after baseline) |
| Interleukin-1β | IL-1β | baseline(1 week before treatment), the 1st month(4 weeks after baseline) |
| C-Reactive protein | CRP | baseline(1 week before treatment), the 1st month(4 weeks after baseline) |
| cortisol | cortisol | baseline(1 week before treatment), the 1st month(4 weeks after baseline) |
| thyrotropin | TSH | baseline(1 week before treatment), the 1st month(4 weeks after baseline) |
| Brain-derived neurotrophic factor | BDNF | baseline(1 week before treatment), the 1st month(4 weeks after baseline) |