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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06452849
Other study ID # PDJW-2024-001CSB
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 adolescent depressive disorders.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date April 28, 2025
Est. primary completion date April 28, 2025
Accepts healthy volunteers No
Gender All
Age group 14 Years to 18 Years
Eligibility Inclusion Criteria: - Participants must be aged between 14 and 18, 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, after treatment, 1 week, 4 weeks and 8 weeks
Primary HAMA Baseline, after treatment, 1 week, 4 weeks and 8 weeks
Primary MADRS Baseline, after treatment, 1 week, 4 weeks and 8 weeks
Primary PHQ-A Baseline, after treatment, 1 week, 4 weeks and 8 weeks
Primary GAD-7 Baseline, after treatment, 1 week, 4 weeks and 8 weeks
Primary SHAPS Baseline, 4 weeks and 8 weeks
Primary PSQI Baseline, 4 weeks and 8 weeks
Primary SF-36 Baseline and 8 weeks
Primary WHOQOL-BREF Baseline and 8 weeks
Primary ARI Baseline and 8 weeks
Primary OSI For use when the patient exhibits self-harming behavior Baseline, 4 weeks and 8 weeks
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