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

Late Life Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05010915
• Other study ID #: 202002467A3
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2022
• Source: Chang Gung Memorial Hospital
• Contact: Shwu-Hua Lee
• Phone: 03-3281200
• Email: shlee[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Late Life Depression
• Suicidal Ideation

Intervention

Device:
• Transcranial magnetic stimulation
Transcranial magnetic stimulation

Locations

Country	Name	City	State
Taiwan	"MAGSTIM" Repetitive transcranial magnetic stimulator(rTMS) System	Taoyuan	Guishan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	Geriatric Depression Scale	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)
Secondary	structural and functional connectivity	Brain MRI connectivity change	baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Secondary	MRI T1	Brain structural volumes (cm)	baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Secondary	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.	baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Secondary	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.	baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Secondary	Verbal Learning & Memory:	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)
Secondary	Interleukin-1	IL-1	baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Secondary	Interleukin-2	IL-2	baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Secondary	Interleukin-6	IL-6	baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Secondary	Interleukin-10	IL-10	baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Secondary	Tumor necrosis factor	TNF-a	baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Secondary	Interleukin-1ß	IL-1ß	baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Secondary	C-Reactive protein	CRP	baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Secondary	cortisol	cortisol	baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Secondary	thyrotropin	TSH	baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Secondary	Brain-derived neurotrophic factor	BDNF	baseline(1 week before treatment), the 1st month(4 weeks after baseline)