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

NCT05010915 | Unknown

• 1 other identifier: 202002467A3
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Late Life Depression

Keywords

TMS; TBS

Outcome Measures

Primary Outcomes (4)

• 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)

Secondary Outcomes (16)

• Geriatric Depression Scale

  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

  baseline(1 week before treatment), the 1st month(4 weeks after baseline)

• MRI T1

  baseline(1 week before treatment), the 1st month(4 weeks after baseline)

• functional MRI (resting-state/biological motion task) - BOLD signal

  baseline(1 week before treatment), the 1st month(4 weeks after baseline)

• Diffusion Tensor Imaging (DTI) - FA

  baseline(1 week before treatment), the 1st month(4 weeks after baseline)

Study Arms (3)

dorsolateral prefrontal cortex

EXPERIMENTAL

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 at least 3 on Question #3 (Suicide: 3 ideas and gestures of suicide) of the HAMD

Device: Transcranial magnetic stimulation

ventrolateral prefrontal cortex

EXPERIMENTAL

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 at least 3 on Question #3 (Suicide: 3 ideas and gestures of suicide) of the HAMD

Device: Transcranial magnetic stimulation

sham comparator

PLACEBO COMPARATOR

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 at least 3 on Question #3 (Suicide: 3 ideas and gestures of suicide) of the HAMD

Device: Transcranial magnetic stimulation

Interventions

Transcranial magnetic stimulation DEVICE

Transcranial magnetic stimulation

dorsolateral prefrontal cortex; sham comparator; ventrolateral prefrontal cortex

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 50 years.
• Major depressive disorder (MDD).
• Right handiness
• with a score ≥ 12 on the Beck Scale of Suicidal Ideation (BSSI) and a score of at least 3 on Question #3 (Suicide: 3 ideas and gestures of suicide) of the HAMD

You may not qualify if:

• Inability to provide informed consent.
• Dementia, as defined by MoCA 23/24. Other major mental or current psychotic symptoms
• Active current suicidal intent as evidenced or the endorsement of an actual attempt, interrupted attempt,
• Have known preexisting noise-induced hearing loss, concurrent treatment with ototoxic medications, or with cochlear implants are on medications known to lower seizure threshold.
• Alcohol or other substances abuse of or dependence on within the past 3 months Organic brain, head trauma,
• Elevated risk of seizure due to TBI
• Participation in concurrent clinical trial
• Non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
• Unstable medical illness, including delirium, malignancy, uncontrolled diabetes mellitus, hypertension, hyperlipidemia, or cerebrovascular or cardiovascular risk factors that are not under medical management. Unstable cardiac disease or recent (\<3m) myocardial infarction
• Mental implement in the brain, claustrophobia
• Ever received ECT, TMS Consent procedures.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

"MAGSTIM" Repetitive transcranial magnetic stimulator(rTMS) System

Taoyuan District, Guishan, 333423, Taiwan

RECRUITING

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Shwu-Hua Lee

  ChungGung memorial hospital

  STUDY CHAIR

Central Study Contacts

Shwu-Hua Lee

CONTACT

03-3281200; shlee@cgmh.org.tw

hsueh-ching tsai, bachelor

CONTACT

03-3281200; stacy.tsai409@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: August 18, 2021
• Study Start: November 1, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: August 22, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)