search
Back to results

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

Primary Purpose

Late Life Depression

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Transcranial magnetic stimulation
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Late Life Depression focused on measuring TMS, TBS

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

dorsolateral prefrontal cortex

ventrolateral prefrontal cortex

sham comparator

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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)
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)
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)

Secondary Outcome Measures

Geriatric Depression Scale
the severity of depression(the score range from 0-15,the higher score means worse outcome)
structural and functional connectivity
Brain MRI connectivity change
MRI T1
Brain structural volumes (cm)
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.
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.
Verbal Learning & Memory:
Word list of Wechsler Memory Scale-III Face memory task
Interleukin-1
IL-1
Interleukin-2
IL-2
Interleukin-6
IL-6
Interleukin-10
IL-10
Tumor necrosis factor
TNF-α
Interleukin-1β
IL-1β
C-Reactive protein
CRP
cortisol
cortisol
thyrotropin
TSH
Brain-derived neurotrophic factor
BDNF

Full Information

First Posted
July 2, 2021
Last Updated
November 7, 2022
Sponsor
Chang Gung Memorial Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05010915
Brief Title
TBS,TMS, Suicidal Ideation, Magnetic Resonance Imaging, Dorsolateral Prefrontal Cortex, Ventrolateral Prefrontal Cortex
Official Title
Theta Burst Stimulation, Transcranial Magnetic Stimulation, Late Life Depression, Suicidal Ideation, Functional Magnetic Resonance Imaging, Dorsolateral Prefrontal Cortex, Ventrolateral Prefrontal Cortex
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Late Life Depression
Keywords
TMS, TBS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dorsolateral prefrontal cortex
Arm Type
Experimental
Arm Description
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
Arm Title
ventrolateral prefrontal cortex
Arm Type
Experimental
Arm Description
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
Arm Title
sham comparator
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation
Intervention Description
Transcranial magnetic stimulation
Primary Outcome Measure Information:
Title
Beck Scale for Suicide Ideation (BSSI) at baseline
Description
the severity of suicide ideation(the score range from 0-38,the higher score indicates higher severity.
Time Frame
baseline(1 week before treatment)
Title
Beck Scale for Suicide Ideation (BSSI)at the 1st month
Description
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)
Title
Beck Scale for Suicide Ideation (BSSI)at the 3rd month
Description
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)
Title
Beck Scale for Suicide Ideation (BSSI)at the 6th month
Description
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)
Secondary Outcome Measure Information:
Title
Geriatric Depression Scale
Description
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)
Title
structural and functional connectivity
Description
Brain MRI connectivity change
Time Frame
baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Title
MRI T1
Description
Brain structural volumes (cm)
Time Frame
baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Title
functional MRI (resting-state/biological motion task) - BOLD signal
Description
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)
Title
Diffusion Tensor Imaging (DTI) - FA
Description
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)
Title
Verbal Learning & Memory:
Description
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)
Title
Interleukin-1
Description
IL-1
Time Frame
baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Title
Interleukin-2
Description
IL-2
Time Frame
baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Title
Interleukin-6
Description
IL-6
Time Frame
baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Title
Interleukin-10
Description
IL-10
Time Frame
baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Title
Tumor necrosis factor
Description
TNF-α
Time Frame
baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Title
Interleukin-1β
Description
IL-1β
Time Frame
baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Title
C-Reactive protein
Description
CRP
Time Frame
baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Title
cortisol
Description
cortisol
Time Frame
baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Title
thyrotropin
Description
TSH
Time Frame
baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Title
Brain-derived neurotrophic factor
Description
BDNF
Time Frame
baseline(1 week before treatment), the 1st month(4 weeks after baseline)

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shwu-Hua Lee
Phone
03-3281200
Ext
3839
Email
shlee@cgmh.org.tw
First Name & Middle Initial & Last Name or Official Title & Degree
hsueh-ching tsai, bachelor
Phone
03-3281200
Ext
3839
Email
stacy.tsai409@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shwu-Hua Lee
Organizational Affiliation
ChungGung memorial hospital
Official's Role
Study Chair
Facility Information:
Facility Name
"MAGSTIM" Repetitive transcranial magnetic stimulator(rTMS) System
City
Taoyuan
State/Province
Guishan
ZIP/Postal Code
333423
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shwu-Hua Lee, Bachelor
Phone
0975365654
Ext
03-3277859
Email
shlee@cgmh.org.tw

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs