Amygdala MRI-TIS for Depression

Safety, Efficacy and Neuroimaging Mechanisms of Amygdala Temporal Interference Stimulation Therapy for Depression

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.

Study Overview

• Status: Recruiting
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Device: Nervio-X

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jingjing HUANG, MD PhD; Phone Number: 021-68306699*1222; Email: jjhuang_att@163.com
• Study Contact Backup: Name: Chencheng Zhang, MD PhD; Email: i@cczhang.org

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Pudong New Area Mental Health Center
      • Contact: Jingjing Huang; Phone Number: 021-68306699*1222

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amygdala TI; Right amygdala Temporal Interference (TI) stimulation with 100 frequency difference, 20 minutes per day for 5 days.	Device: Nervio-X; An 8-channel TIS device developed by NEURODOME Corporation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HAMD-17	Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSQI		Baseline, 4 weeks and 8 weeks
SF-36		Baseline and 8 weeks
WHOQOL-BREF		Baseline and 8 weeks
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
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
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
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
GAD-7		Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
QIDS-SR		Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
MADRS		Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks

Collaborators and Investigators

• Sponsor: Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
• Collaborators: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2024
• Primary Completion (Estimated): April 28, 2025
• Study Completion (Estimated): April 28, 2025

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Deep Brain Stimulation; Major Depressive Disorder; TI stimulation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: PDJW-2024-001CSA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No