Amygdala TIS for Depression

A Multicenter, Randomized, Controlled, Double-Blind Trial on the Efficacy and Safety of Amygdala Temporal Interference Stimulation for the Treatment of Depression.

The current investigation employs a directed neuromodulation technique, specifically targeting the right amygdala, to ascertain its therapeutic efficacy in managing depressive episodes. The intervention's safety and efficacy will be evaluated using an assessment incorporating depressive symptomatology, cognitive abilities, and daily functions.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai East Hospital
  • Tianjin, China
    • Tianjin Anding Hospital (Mental Health Center of Tianjin Medical University)
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital

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 disorders such as schizophrenia, 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: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amygdala TI; 5 sessions will be delivered in 3 weeks	Device: Nervio-X; An 8-channel TIS device developed by NEURODOME Corporation.
Sham Comparator: Controlled TI; 5 sessions will be delivered in 3 weeks	Device: Nervio-X; An 8-channel TIS device developed by NEURODOME Corporation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quick Inventory of Depressive Symptomatology - Self-Report (16-item version)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Depression Rating Scale (17-item version)		Baseline, 1 week, 4 weeks and 8 weeks
Snaith-Hamilton Pleasure Scale	The SHAPS is a questionnaire that used to measure the severity of anhedonia, a common symptom in various mental health conditions.	Baseline, 1 week, 4 weeks and 8 weeks
Hamilton Anxiety Rating Scale		Baseline, 4 weeks and 8 weeks
Pittsburgh Sleep Quality Index		Baseline, 4 weeks and 8 weeks
36-Item Short Form Health Survey		Baseline and 8 weeks
World Health Organization Quality of Life Assessment - Brief Version		Baseline and 8 weeks
Quick Inventory of Depressive Symptomatology - Self-Report (16-item version)		Baseline, 1 week and 8 weeks

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: Shanghai East Hospital; Tianjin Anding Hospital
• Investigators: Principal Investigator: Yiru Fang, MD PhD, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2024
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Deep Brain Stimulation; Amygdala; Non-invasive; TI; Temporal Interference
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 2024LLSD160-001

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
• product manufactured in and exported from the U.S.: No