Late Life DepressionNCT05010915
TBS,TMS, Suicidal Ideation, Magnetic Resonance Imaging, Dorsolateral Prefrontal Cortex, Ventrolateral Prefrontal Cortex
A study testing Transcranial magnetic stimulation in people with Late Life Depression, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Late Life Depression
- What is being tested?
- Transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2021to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
"MAGSTIM" Repetitive transcranial magnetic stimulator(rTMS) System
Taoyuan, Guishan, 333423
Shwu-Hua Lee, Bachelor, 0975365654 ext. 03-3277859, shlee@cgmh.org.tw
About this study
Official title: 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.
Read the 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.
- Conditions
- Late Life Depression
- Being tested
- Transcranial magnetic stimulation
- Keywords
- TMS, TBS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationDevice
Transcranial magnetic stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Device: Transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: the 6th month(24 weeks after baseline)
Secondary outcomes (16)
Geriatric Depression Scale
the severity of depression(the score range from 0-15,the higher score means worse outcome)
Measured: 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
Brain MRI connectivity change
Measured: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
MRI T1
Brain structural volumes (cm)
Measured: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
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.
Measured: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
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.
Measured: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Verbal Learning & Memory:
Word list of Wechsler Memory Scale-III Face memory task
Measured: baseline(1 week before treatment), the 1st month(4 weeks after baseline) and the 6th month(24 weeks after baseline)
Interleukin-1
IL-1
Measured: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Interleukin-2
IL-2
Measured: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Interleukin-6
IL-6
Measured: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Interleukin-10
IL-10
Measured: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Tumor necrosis factor
TNF-α
Measured: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Interleukin-1β
IL-1β
Measured: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
C-Reactive protein
CRP
Measured: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
cortisol
cortisol
Measured: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
thyrotropin
TSH
Measured: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Brain-derived neurotrophic factor
BDNF
Measured: baseline(1 week before treatment), the 1st month(4 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start1 Nov 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Life DepressionStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shwu-Hua Lee, Study chair, ChungGung memorial hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010915
- Sponsor's protocol ID
- 202002467A3
- Status last verified
- Aug 2023
- First submitted
- 2 Jul 2021
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theta Burst Stimulation, Transcranial Magnetic Stimulation, Late Life Depression, Suicidal Ideation, Functional Magnetic Resonance Imaging, Dorsolateral Prefrontal Cortex, Ventrolateral Prefrontal Cortex
- ClinicalTrials.gov ID
- NCT05010915
- Acronym / sponsor ID
- 202002467A3
- Conditions
- Late Life Depression
- Keywords
- TMS, TBS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dorsolateral prefrontal cortex | Experimental | Device: Transcranial magnetic stimulation1. 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 |
| ventrolateral prefrontal cortex | Experimental | Device: Transcranial magnetic stimulation1. 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 |
| sham comparator | Placebo comparator | Device: Transcranial magnetic stimulation1. 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulationTranscranial magnetic stimulation | Device | dorsolateral prefrontal cortex, sham comparator, ventrolateral prefrontal cortex |
Primary outcome
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.
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)
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)
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)
16 secondary outcomes
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)
structural and functional connectivity
Time frame: 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)
functional MRI (resting-state/biological motion task) - BOLD signal
Time frame: 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)
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)
Interleukin-1
Time frame: 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)
Interleukin-6
Time frame: 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)
Tumor necrosis factor
Time frame: 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)
C-Reactive protein
Time frame: 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)
thyrotropin
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shwu-Hua Lee study chair
ChungGung memorial hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation in people with Late Life Depression, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shwu-Hua Lee (03-3281200 ext. 3839, shlee@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Scale for Suicide Ideation (BSSI) at baseline (time frame: baseline(1 week before treatment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.