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Independently Developed Navigation Systems for Precise Transcranial Magnetic Stimulation and Its Application in Depression: a Randomized Controlled Trial.

Independently Developed Navigation Systems for Precise Transcranial Magnetic Stimulation and Its Application in Depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035259
Enrollment
Unknown
Registered
2020-08-05
Start date
2021-03-31
Completion date
Unknown
Last updated
2024-11-18

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

Conditions

Major depressvie disorder

Interventions

Precise TMS group :Precise TMS using 3D printed localizer
Conventional TMS control group (1):conventional TMS without precisely targeting (1)
Precise TMS group:Precise TMS using augmented reality (AR)-based navigator
Conventional TMS control group (2):conventional TMS without precisely targeting (2)

Sponsors

Shanghai Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the diagnostic criteria of major depressive disorder in dsm-5 (by SCID and clinical diagnosis by a chief physician); 2. Patients who agreed to receive rTMS treatment; 3. Patients aged 18-65 years old; 4. Subjects with junior high school education or above; 5. First or recurrent patients; 6. Subjects with HAMD-17 score >= 14; 7. Patients who failed to receive a full dose of SSRI antidepressant or were intolerant of at least one antidepressant; 8. Patients with no change of drug treatment dose 2 weeks before enrollment.

Exclusion criteria

Exclusion criteria: 1. Patients with substance related disorders diagnosed by dsm-5 in recent three months; 2. Patients with schizophrenia and other primary psychotic disorders, obsessive-compulsive disorder, post-traumatic stress disorder, anxiety disorder and personality disorder diagnosed by dsm-5; 3. Patients with serious heart disease or pacemaker implantation; 4. Patients with serious negative ideas and behaviors; 5. Pregnant or lactating women; 6. Patients who had been treated with ECT or TMS were ineffective; 7. Patients with any nervous system diseases, including intracranial injury, epilepsy, Parkinson's disease, etc; 8. Patients with intracranial metal implants or other contraindications for TMS treatment; 9. Patients with anticonvulsant drugs or more than 2mg of diazepam; 10. Patients with claustrophobia.

Design outcomes

Primary

MeasureTime frame
Change of HAMD-17 scores;

Secondary

MeasureTime frame
Changes of HAMA-14 scores;Neuroimgaing biomarkers;

Countries

China

Contacts

Public ContactYingying Tang

Shanghai Mental Health Center

yytang0522@gmail.com+86 133 1161 7905

Outcome results

None listed

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