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Insular Neural Network Involvement in the Pathological Mechanisms of Depression and the Mechanism of Individualized Targeted aiTBS Therapy

Insular Neural Network Involvement in the Pathological Mechanisms of Depression and the Mechanism of Individualized Targeted aiTBS Therapy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125320
Enrollment
Unknown
Registered
2026-05-25
Start date
2025-01-06
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Interventions

Depression group (Research content 1: The role of insular neural networks in the pathogenesis of depression):None
Healthy control group (Research content 1: The role of insular neural networks in the pathogenesis of depression):None
True stimulation group (Research content 2: The role of insular neural networks in individualized targeted iTBS treatment mechanism for depression):Real stimulation intervention via neuronavigation-gu
10 sessions per day, 1800 pulses per session, 50 minutes rest between each two sessions, continuous intervention for 5 days
Sham stimulation group (Research content 2: The role of insular neural networks in individualized targeted iTBS treatment mechanism for depression):Using a sham stimulation coil
the sham coil has a similar appearance to the real coil and can simulate the sound of real stimulation, but does not produce actual stimulation
stimulation parameters are the same as the true stimulation group

Sponsors

Hebei Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria for Depression Group 1 Meet the diagnostic criteria for depression specified in the *Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)*, without psychotic symptoms, confirmed by clinical evaluation and Mini International Neuropsychiatric Interview (MINI). 2 The score of the 17-item Hamilton Depression Rating Scale (HAMD-17) of subjects is >= 18 points during the screening period and baseline period. 3 Age ranges >= 18 years old and = 4 weeks before enrollment. 5 All subjects are right-handed. 6 Voluntarily sign the informed consent form. Inclusion Criteria for Healthy Control Group 1 Healthy community volunteers. 2 Age ranges >= 18 years old and <= 60 years old (inclusive), with no restriction on gender. 3 The score of the 17-item Hamilton Depression Rating Scale (HAMD-17) is < 7 points. 4 All subjects are right-handed. 5 Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion Criteria for Depression Group 1 Meet the diagnostic criteria for other mental disorders specified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). 2 Have contraindications for magnetic resonance scanning (such as having a cardiac pacemaker) or contraindications for rTMS treatment. 3 Have clearly diagnosed neurological diseases (e.g., epilepsy); complicated with organic brain diseases and a history of severe traumatic brain injury; have severe or unstable physical diseases. 4 Have received TMS treatment before participating in the trial. 5 Have received ECT or light therapy within three months. 6 Have no response to ECT treatment (> 8 times). 7 Have previously received antidepressant treatment with implanted devices (e.g., DBS, VNS). 8 Pregnant or lactating women. 9 Have significant suicide risk. 10 Have difficulty in verbal communication and cannot cooperate with treatment and evaluation. 11 Currently participating in other clinical trials. Exclusion Criteria for Healthy Control Group 1 Positive family history of mental illness. 2 Suffering from mental illness, neurological diseases, severe physical diseases, etc. 3 Pregnant or lactating women. 4 Have contraindications for magnetic resonance scanning (such as having a cardiac pacemaker).

Design outcomes

Primary

MeasureTime frame
Structural characteristics (volume, surface area, etc.);Functional characteristics (parameters such as functional connectivity);Electroencephalographic features (microstate, functional connectivity, brain networks, etc.);

Countries

China

Contacts

Public ContactZhang Yunshu

Hebei Mental Health Center

yunshucoffee@sina.com+86 155 3322 2271

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026