TBS,TMS, Suicidal Ideation, Magnetic Resonance Imaging, Dorsolateral Prefrontal Cortex, Ventrolateral Prefrontal Cortex

Last updated: August 20, 2024
Sponsor: Chang Gung Memorial Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Suicide

Depression

Treatment

Transcranial magnetic stimulation

Clinical Study ID

NCT05010915
202002467A3
  • Ages > 50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age > 50 years.

  2. Major depressive disorder (MDD).

  3. Right handiness

  4. with a score ≥ 12 on the Beck Scale of Suicidal Ideation (BSSI) and a score of atleast 3 on Question #3 (Suicide: 3 ideas and gestures of suicide) of the HAMD

Exclusion

Exclusion Criteria:

  1. Inability to provide informed consent.

  2. Dementia, as defined by MoCA 23/24. Other major mental or current psychotic symptoms

  3. Active current suicidal intent as evidenced or the endorsement of an actual attempt,interrupted attempt,

  4. Have known preexisting noise-induced hearing loss, concurrent treatment withototoxic medications, or with cochlear implants are on medications known to lowerseizure threshold.

  5. Alcohol or other substances abuse of or dependence on within the past 3 monthsOrganic brain, head trauma,

  6. Elevated risk of seizure due to TBI

  7. Participation in concurrent clinical trial

  8. Non-correctable clinically significant sensory impairment (i.e., cannot hear wellenough to cooperate with interview).

  9. Unstable medical illness, including delirium, malignancy, uncontrolled diabetesmellitus, hypertension, hyperlipidemia, or cerebrovascular or cardiovascular riskfactors that are not under medical management. Unstable cardiac disease or recent (<3m) myocardial infarction

  10. Mental implement in the brain, claustrophobia

  11. Ever received ECT, TMS Consent procedures.

Study Design

Total Participants: 125
Treatment Group(s): 1
Primary Treatment: Transcranial magnetic stimulation
Phase:
Study Start date:
November 01, 2021
Estimated Completion Date:
September 30, 2024

Study Description

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.

Connect with a study center

  • "MAGSTIM" Repetitive transcranial magnetic stimulator(rTMS) System

    Taoyuan, Guishan 333423
    Taiwan

    Active - Recruiting

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