Temporal Interference Stimulation of Amygdala and dLPFC: A Randomized Controlled Trial for Adolescent Depression

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 18
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Shanghai Pudong New Area Mental Health Center
RECRUITING
Shanghai
Contact Information
Primary
JINGJING HUANG, MD PhD
jjhuang_att@163.com
021-68306699*1222
Backup
Chencheng Zhang, MD PhD
i@cczhang.org
18217122884
Time Frame
Start Date: 2024-05-27
Estimated Completion Date: 2025-04-28
Participants
Target number of participants: 60
Treatments
Experimental: Amygdala TI
Right amygdala Temporal Interference (TI) stimulation with 100 frequency difference, 20 minutes per day for 5 days.
Experimental: dLPFC TI
L\_dLPFC TI Temporal Interference (TI) stimulation with 10 frequency difference, 20 minutes per day for 5 days.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
Collaborators: Ruijin Hospital

This content was sourced from clinicaltrials.gov