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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06461260
Other study ID # PDJW-2024-001CSA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 27, 2024
Est. completion date April 28, 2025

Study information

Verified date June 2024
Source Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
Contact Jingjing HUANG, MD PhD
Phone 021-68306699*1222
Email jjhuang_att@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study utilizes a non-invasive deep brain stimulation (temporal interference, TI) technique primarily targeting the amygdala to preliminarily explore the clinical efficacy and potential mechanisms of MRI-compatible TI technology in regulating the amygdala in depressive disorders, providing a more comprehensive basis for the application of TI technology.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date April 28, 2025
Est. primary completion date April 28, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Participants must be aged between 18 and 65, with no gender restrictions; - A diagnosis of depression made by the study physician based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); - HAMD-17 score of 17 or higher; - Participants must not have changed their antidepressant medication regimen from 30 days prior to signing the informed consent form through the duration of the experiment; - Eligible individuals or their authorized representatives must demonstrate, as assessed by the study physician, a comprehensive understanding of the study's objectives and procedures, be capable of adhering to the requirements set forth in the study protocol, and provide their signature on the informed consent form. Exclusion Criteria: - Eligible participants must not have a history of psychiatric or neurological disorders, as judged by the investigator, which may impact the evaluation of the study's efficacy; - Participants must not have a history of seizures or prior episodes of epilepsy; - The presence of metallic foreign objects within the cranial structure or metallic cardiac implants; - Participants must not have a diagnosis of organic brain disease, nor a history of significant cranial trauma or neurosurgical intervention; - Participants received electroconvulsive therapy or other physical therapies (such as transcranial magnetic stimulation therapy); - The researcher evaluated the individual's mental state and determined it to present a significant risk of suicidal ideation or behavior; - Pregnant or breastfeeding; - Participants who are concurrently engaged in other clinical interventional trials; - Participants presenting with other circumstances that the investigator deems unsuitable for the intervention being studied

Study Design


Intervention

Device:
Nervio-X
An 8-channel TIS device developed by NEURODOME Corporation.

Locations

Country Name City State
China Shanghai Pudong New Area Mental Health Center Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary HAMD-17 Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
Secondary HAMA HAMA is a questionnaire that designed to evaluate the presence and intensity of anxiety symptoms in both clinical and research settings. Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
Secondary SHAPS The SHAPS is a questionnaire that used to measure the severity of anhedonia, a common symptom in various mental health conditions. Baseline, 4 weeks and 8 weeks
Secondary SF-36 Baseline and 8 weeks
Secondary WHOQOL-BREF Baseline and 8 weeks
Secondary PSQI Baseline, 4 weeks and 8 weeks
Secondary THINC-it® THINC-it® is a screening tool for assessment of cognitive functioning in patients with a major depressive episode/disorder Baseline, treatment completion day and 8 weeks
Secondary Blood sample Peripheral blood will be collected at baseline and one 4 weeks after treatment for transcriptomic and proteomic studies to explore the molecular mechanisms of temporal interference (TI) in the treatment of depressive disorders and to identify molecular markers for predicting therapeutic efficacy Baseline, 4 weeks
Secondary GAD-7 Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
Secondary QIDS-SR Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
Secondary MADRS Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
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