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Clinical efficacy and brain imaging mechanisms of individualised TMS for depressive disorders

Clinical efficacy and brain imaging mechanisms of individualised TMS for depressive disorders

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091689
Enrollment
Unknown
Registered
2024-11-01
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-11-04

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

Conditions

depressive disorder

Interventions

Individualised vmPFC, AMG TMS treatment group:Individualised TMS treatment with vmPFC, AMG as deep effector brain regions
Individualised sgACC TMS treatment group:Individualised TMS treatment with sgACC as a deep effector brain region
5cm positioning TMS treatment group:Traditional 5cm positioning method TMS treatment

Sponsors

The Third Hospital of Inner Mongolia Autonomous Region
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. be aged 18-65 years and have signed an informed consent form; 2. have adequate comprehension and =9 years of cultural education; 3. Han Chinese, right-handed; 4. meet the diagnostic criteria for depressive disorders in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) and pass the DSM-5 Definitive Clinical Examination of Disorders (SCID-5) screening; 5. have a total HAMD-17 score of =17.

Exclusion criteria

Exclusion criteria: 1. Excluding those with severe cardiac, hepatic and renal insufficiency; and 2. exclude schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, neurocognitive disorders, substance-related and addictive disorders, and other psychiatric disorders caused by physical illnesses or medications, as well as serious suicidal tendencies; 3. have recently received physiotherapy, such as rTMS, DBS, etc.; or have been treated by a physiotherapist. 3. Recent physical therapy such as rTMS, DBS, etc. 4. pregnant women or women = 6 months after delivery or breastfeeding; and 5. Inability to read and understand the information sheet and the informed consent form or the patient self-assessment scale. 6. Participating in other clinical trials. 7. History of traumatic brain injury or organic brain disease. 8. Patients with metallic or electronic devices, such as cochlear implants, pacemakers, stents, or other metallic foreign objects in their bodies; and 9. Patients with seizure risk or other contraindications to cranial MRI and TMS.

Design outcomes

Primary

MeasureTime frame
Change in 24-Hamilton Depression Scale before and after treatment;

Secondary

MeasureTime frame
Change in Hamilton anxiety scale before and after treatment;Changes in the Montgomery-Eisenberg Depression Rating Scale before and after treatment;Changes in the 9-item Patient Health Questionnaire before and after treatment;Changes in the Snaith-Hamilton Pleasure Scale before and after treatment;Change in Beck Depression Questionnaire before and after treatment;Changes in Rumination Thinking Scale before and after treatment;Treatment Emergent Symptom Scale post-treatment scores;Changes in the Pittsburgh Sleep Quality Index Scale before and after treatment;Change in insomnia severity index scale before and after treatment;Changes in functional connectivity before and after treatment;Changes in local activity indicators before and after treatment;

Countries

China

Contacts

Public ContactDongsheng Lv

The Third Hospital of Inner Mongolia Autonomous Region

dongshenglv@163.com+86 138 4881 0596

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026