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

August 20, 2024 updated by: Chang Gung Memorial Hospital

Theta Burst Stimulation, Transcranial Magnetic Stimulation, Late Life Depression, Suicidal Ideation, Functional Magnetic Resonance Imaging, Dorsolateral Prefrontal Cortex, Ventrolateral Prefrontal Cortex

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
    • Guishan
      • Taoyuan, Guishan, Taiwan, 333423
        • Recruiting
        • "MAGSTIM" Repetitive transcranial magnetic stimulator(rTMS) System
        • Contact:
          • Shwu-Hua Lee, Bachelor
          • Phone Number: 03-3277859 0975365654
          • Email: shlee@cgmh.org.tw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

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 with ototoxic medications, or with cochlear implants are on medications known to lower seizure threshold.
  5. Alcohol or other substances abuse of or dependence on within the past 3 months Organic 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 well enough to cooperate with interview).
  9. 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
  10. Mental implement in the brain, claustrophobia
  11. Ever received ECT, TMS Consent procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: dorsolateral prefrontal cortex
  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
Transcranial magnetic stimulation
Experimental: ventrolateral prefrontal cortex
  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
Transcranial magnetic stimulation
Placebo Comparator: sham 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
Transcranial magnetic stimulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Beck Scale for Suicide Ideation (BSSI) at baseline
Time Frame: baseline(1 week before treatment)
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
Time Frame: the 1st month (4 weeks after baseline)
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
Time Frame: the 3rd month(12 weeks after baseline)
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
Time Frame: the 6th month(24 weeks after baseline)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Geriatric Depression Scale
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)
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
Time Frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Brain MRI connectivity change
baseline(1 week before treatment), the 1st month(4 weeks after baseline)
MRI T1
Time Frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
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
Time Frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
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
Time Frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
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:
Time Frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline) and the 6th month(24 weeks after baseline)
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
Time Frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
IL-1
baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Interleukin-2
Time Frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
IL-2
baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Interleukin-6
Time Frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
IL-6
baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Interleukin-10
Time Frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
IL-10
baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Tumor necrosis factor
Time Frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
TNF-α
baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Interleukin-1β
Time Frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
IL-1β
baseline(1 week before treatment), the 1st month(4 weeks after baseline)
C-Reactive protein
Time Frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
CRP
baseline(1 week before treatment), the 1st month(4 weeks after baseline)
cortisol
Time Frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
cortisol
baseline(1 week before treatment), the 1st month(4 weeks after baseline)
thyrotropin
Time Frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
TSH
baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Brain-derived neurotrophic factor
Time Frame: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
BDNF
baseline(1 week before treatment), the 1st month(4 weeks after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Shwu-Hua Lee, ChungGung memorial hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202002467A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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