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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
125
Transcranial magnetic stimulation
"MAGSTIM" Repetitive transcranial magnetic stimulator(rTMS) System
Taoyuan District, Guishan, Taiwan
RECRUITINGBeck Scale for Suicide Ideation (BSSI) at baseline
the severity of suicide ideation(the score range from 0-38,the higher score indicates higher severity.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: the 6th month(24 weeks after baseline)
Geriatric Depression Scale
the severity of depression(the score range from 0-15,the higher score means worse outcome)
Time frame: 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
Brain MRI connectivity change
Time frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
MRI T1
Brain structural volumes (cm)
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Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline) and the 6th month(24 weeks after baseline)
Interleukin-1
IL-1
Time frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Interleukin-2
IL-2
Time frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Interleukin-6
IL-6
Time frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Interleukin-10
IL-10
Time frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Tumor necrosis factor
TNF-α
Time frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Interleukin-1β
IL-1β
Time frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
C-Reactive protein
CRP
Time frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
cortisol
cortisol
Time frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
thyrotropin
TSH
Time frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Brain-derived neurotrophic factor
BDNF
Time frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)