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Research on New Technologies for the Diagnosis and Treatment of Neuropsychiatric Disorders — Development of Non-Invasive Multimodal Electromagnetic Precision Regulation Technologies and Products

Research on New Technologies for the Diagnosis and Treatment of Neuropsychiatric Disorders — Development of Non-Invasive Multimodal Electromagnetic Precision Regulation Technologies and Products

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114418
Enrollment
Unknown
Registered
2025-12-11
Start date
2025-07-22
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Major depressive disorder

Interventions

Real Transcranial Magnetic and Electrical Stimulation Group:After applying tDCS to the left DLPFC at 2 mA for 20 minutes, immediately administer 10 minutes of iTBS-pattern magnetic stimulation. Treat
Sham Transcranial Magnetic and Electrical Stimulation Group:After applying sham tDCS to the left DLPFC at 2 mA for 20 minutes, immediately administer 10 minutes of iTBS-pattern magnetic stimulation. T

Sponsors

Hangzhou Seventh People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Patient interviews were conducted using the DSM-5 Disorder Regular Clinical Examination Interview Manual (Clinical Edition) (SCID-5-CV), which was in line with the diagnostic criteria of major depressive disorder in DSM-5. 2. Assessed as right-handed by the Edinburgh Pareto Scale; 3. Applicants must be between 18 and 65 years old, with no gender restrictions, and have a junior high school education or above. 4. The score of the Montgomery Depression Rating Scale is greater than or equal to 20 points, and the score of the 24 items of the Hamilton Depression Scale is greater than or equal to 20 points. 5. Before randomization, no antidepressant drugs were used or the current antidepressant treatment plan was stably used for at least 4 weeks. 6. Possess the listening, speaking, reading, writing and comprehension abilities required to complete this research. 7. Be able to provide informed consent and comply with research procedures.

Exclusion criteria

Exclusion criteria: Patient interviews were conducted using SCID-5-CV, which met the diagnostic criteria for other mental disorders in DSM-5, including schizophrenia spectrum disorder, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depressive disorders caused by substances and/or drugs, and depressive disorders caused by other medical problems. 2. Medical history: Those with a history of severe physical illness, major head trauma, organic brain diseases, or neurological disorders; 3. Contraindications for TMS, tDCS stimulation or fMRI scans: Individuals with pacemakers, cochlear implants or other metal foreign bodies and any electronic devices implanted in the body, those with claustrophobia or other contraindications for magnetic resonance scans, and those who have not passed the transcranial magnetic stimulation adult safety screening (TASS), etc. 4. History of epilepsy in individuals or first-degree relatives: Individuals or first-degree relatives have had at least two non-induced epileptic seizures with an interval of more than 24 hours, or have been diagnosed with epilepsy syndrome, or have had epileptic seizures within the past 12 months; 5. History of physical intervention: Those who have received electroconvulsive therapy (ECT), electroconvulsive therapy (TMS), or light therapy within 3 months; 6. History of substance abuse: Substance use disorder within 6 months or recent substance abuse; Within 24 hours before the experiment, any drug known to significantly lower the threshold for epileptic seizures was used, or alcohol, caffeine and nicotine were consumed; 7. Recent poisoning, insomnia, excessive fatigue, intense exercise, pregnant women or those planning to become pregnant in the near future (in March).

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale score;Montgomery Depression Rating Scale score;Excitability of the DLPFC region;

Secondary

MeasureTime frame
Hamilton Anxiety Scale score;Pittsburgh Sleep Quality Index,PSQI;Chinese Brief Cognitive Test,C-BCT;

Countries

China

Contacts

Public ContactDeng Wei

Hangzhou Seventh People's Hospital

dengw@zju.edu.cn+86 134 8403 6877

Outcome results

None listed

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