Amygdala and dLPFC MRI-TIS for Depression in Adolescents

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06452849
• Other study ID #: PDJW-2024-001CSB
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

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