TBS,TMS, Suicidal Ideation, Magnetic Resonance Imaging, Dorsolateral Prefrontal Cortex, Ventrolateral Prefrontal Cortex
- Conditions
- Late Life Depression
- Registration Number
- NCT05010915
- Lead Sponsor
- Chang Gung Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 125
Inclusion Criteria:<br><br> 1. Age > 50 years.<br><br> 2. Major depressive disorder (MDD).<br><br> 3. Right handiness<br><br> 4. with a score = 12 on the Beck Scale of Suicidal Ideation (BSSI) and a score of at<br> least 3 on Question #3 (Suicide: 3 ideas and gestures of suicide) of the HAMD<br><br>Exclusion Criteria:<br><br> 1. Inability to provide informed consent.<br><br> 2. Dementia, as defined by MoCA 23/24. Other major mental or current psychotic symptoms<br><br> 3. Active current suicidal intent as evidenced or the endorsement of an actual attempt,<br> interrupted attempt,<br><br> 4. Have known preexisting noise-induced hearing loss, concurrent treatment with<br> ototoxic medications, or with cochlear implants are on medications known to lower<br> seizure threshold.<br><br> 5. Alcohol or other substances abuse of or dependence on within the past 3 months<br> Organic brain, head trauma,<br><br> 6. Elevated risk of seizure due to TBI<br><br> 7. Participation in concurrent clinical trial<br><br> 8. Non-correctable clinically significant sensory impairment (i.e., cannot hear well<br> enough to cooperate with interview).<br><br> 9. Unstable medical illness, including delirium, malignancy, uncontrolled diabetes<br> mellitus, hypertension, hyperlipidemia, or cerebrovascular or cardiovascular risk<br> factors that are not under medical management. Unstable cardiac disease or recent<br> (<3m) myocardial infarction<br><br> 10. Mental implement in the brain, claustrophobia<br><br> 11. Ever received ECT, TMS Consent procedures.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Beck Scale for Suicide Ideation (BSSI) at baseline;Beck Scale for Suicide Ideation (BSSI)at the 1st month;Beck Scale for Suicide Ideation (BSSI)at the 3rd month;Beck Scale for Suicide Ideation (BSSI)at the 6th month
- Secondary Outcome Measures
Name Time Method Geriatric Depression Scale;structural and functional connectivity;MRI T1;functional MRI (resting-state/biological motion task) - BOLD signal;Diffusion Tensor Imaging (DTI) - FA;Verbal Learning & Memory:;Interleukin-1;Interleukin-2;Interleukin-6;Interleukin-10;Tumor necrosis factor;Interleukin-1ß;C-Reactive protein;cortisol;thyrotropin;Brain-derived neurotrophic factor