Early Identification of TRD and Construction and Clinical Validation of NTBS Precision Technology
Treatment-Resistant Depression
About this trial
This is an interventional other trial for Treatment-Resistant Depression focused on measuring non-invasive transcranial deep brain stimulation, Temporal Interference Stimulation, depression, early recognition
Eligibility Criteria
Inclusion Criteria: This episode meets the diagnostic criteria of DSM-5 major depression, and is not accompanied by psychotic symptoms in the first episode or relapse of unmedicated depression; 24 item Hamilton Depression Scale (HAMD-24)≥20; Age 18-60, gender unlimited; right hand; Han Chinese; Sign a written informed consent and be willing to participate in the study and be evaluated. Exclusion Criteria: Comorbidities with other mental disorders, including schizophrenia, mental retardation, substance dependence, etc. Patients with metal objects in the body or other contraindications for MRI scanning; Suffering from a serious or unstable physical disease; Positive urine HCG test results of pregnant and lactating women and women of childbearing age during screening; Other conditions deemed unsuitable for participation in the clinical trial by the investigator.
Sites / Locations
- The First Affiliated Hospital of Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
No Intervention
Experimental
Experimental
Experimental
Sham Comparator
Experimental
Experimental
Sham Comparator
No Intervention
non-TRD
TRD Target stimulation A
TRD Target stimulation B
TRD Target stimulation C
TRD sham stimulation
TRD closed-loop stimulation
HC experimental stimulation
HC sham stimulation
HC observation
Patients with first episode or relapse of untreated depression group are treated with escitalopram for 8 weeks, and if effective, they are included in the n-TRD group. If ineffective, Venlafaxine is used for full treatment for 8 weeks; if effective, the patients are included in the non-TRD group. The subjects get clinical evaluation, blood sample collection, magnetic resonance scanning, and electrophysiological monitoring.
Patients do not respond favorably to two antidepressants. The subjects get clinical evaluation, blood sample collection, magnetic resonance scanning, and electrophysiological monitoring. Regimen: Receiving TIS intervention with target A (Characteristic abnormal brain region targets based on data-driven exploration) for 10 times, once a day (except weekends and holidays) for 2 weeks. Stimulation(130Hz, 2mA total current intensity, each stimulation lasts for 30 minutes, 15 seconds respectively for import and exit).
Patients do not respond favorably to two antidepressants. The subjects get clinical evaluation, blood sample collection, magnetic resonance scanning, and electrophysiological monitoring. Regimen: Receiving TIS intervention with target B (Characteristic abnormal brain region targets based on data-driven exploration) for 10 times, once a day (except weekends and holidays) for 2 weeks. Stimulation(130Hz, 2mA total current intensity, each stimulation lasts for 30 minutes, 15 seconds respectively for import and exit).
Patients do not respond favorably to two antidepressants. The subjects get clinical evaluation, blood sample collection, magnetic resonance scanning, and electrophysiological monitoring. Regimen: Receiving TIS intervention with target C (Characteristic abnormal brain region targets based on data-driven exploration) for 10 times, once a day (except weekends and holidays) for 2 weeks. Stimulation(130Hz, 2mA total current intensity, each stimulation lasts for 30 minutes, 15 seconds respectively for import and exit).
Patients do not respond favorably to two antidepressants. The subjects get clinical evaluation, blood sample collection, magnetic resonance scanning, and electrophysiological monitoring. Regimen: sham stimulation for 10 times, once a day (except weekends and holidays) for 2 weeks. Stimulation(130Hz, 2mA total current intensity, each stimulation lasts for 30 seconds, total wearing the instrument for 30 minutes)
Patients do not respond favorably to two antidepressants. The subjects get clinical evaluation, blood sample collection, magnetic resonance scanning, and electrophysiological monitoring. Patients receive closed-loop stimulation guided by EEG phase, and the stimulation target is the effective deep brain region target verified in this study. Regimen: stimulation for 10 times, once a day (except weekends and holidays) for 2 weeks. Stimulation(130Hz, 2mA total current intensity, each stimulation lasts for 30 minutes, 15 seconds respectively for import and exit)
The subjects get clinical evaluation, blood sample collection, magnetic resonance scanning, and electrophysiological monitoring. HC will receive TIS intervention in the exercise area for one time, the stimulation scheme adopted 20 Hz and 2mA total current intensity, and each stimulation lasted for 30 minutes (15 seconds respectively for lead-in and withdrawal)
The subjects get clinical evaluation, blood sample collection, magnetic resonance scanning, and electrophysiological monitoring. Electrode placement, current intensity and intervention times are consistent with those of TIS regimen. 20 Hz, 2mA total current intensityis used, but only lasted for 30 seconds, and then the current is 0 for a total of 30 minutes.
Collect data on healthy controls without stimulation. The subjects get clinical evaluation, blood sample collection, magnetic resonance scanning, and electrophysiological monitoring.