Amygdala MRI-TIS for Depression

Not Applicable

Recruiting

• Conditions: Major Depressive Disorder
• Interventions: Device: Nervio-X

• Registration Number: NCT06461260
• Lead Sponsor: Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-27
• Study First Submitted: 2024-05-31
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-11
• Last Update Submitted: 2024-06-11
• Study First Posted: 2024-06-14
• Last Update Posted: 2024-06-14
• Primary Completion: 2025-04-28
• Study Completion: 2025-04-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amygdala TI	Nervio-X	Right amygdala Temporal Interference (TI) stimulation with 100 frequency difference, 20 minutes per day for 5 days.

Primary Outcome Measures

Name	Time	Method
HAMD-17	Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks

Secondary Outcome Measures

Name	Time	Method
SHAPS	Baseline, 4 weeks and 8 weeks	The SHAPS is a questionnaire that used to measure the severity of anhedonia, a common symptom in various mental health conditions.
SF-36	Baseline and 8 weeks
WHOQOL-BREF	Baseline and 8 weeks
PSQI	Baseline, 4 weeks and 8 weeks
GAD-7	Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
MADRS	Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
Blood sample	Baseline, 4 weeks	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
HAMA	Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks	HAMA is a questionnaire that designed to evaluate the presence and intensity of anxiety symptoms in both clinical and research settings.
THINC-it®	Baseline, treatment completion day and 8 weeks	THINC-it® is a screening tool for assessment of cognitive functioning in patients with a major depressive episode/disorder
QIDS-SR	Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks

Trial Locations

Locations (1)

Shanghai Pudong New Area Mental Health Center; 🇨🇳 Shanghai, Shanghai, China