Amygdala MRI-TIS for Depression

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06461260
• Other study ID #: PDJW-2024-001CSA
• 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 depressive disorders, providing a more comprehensive basis for the application of TI technology.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 28, 2025
• Est. primary completion date: April 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

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, treatment completion day, 1 week, 4 weeks and 8 weeks
Secondary	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
Secondary	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
Secondary	SF-36		Baseline and 8 weeks
Secondary	WHOQOL-BREF		Baseline and 8 weeks
Secondary	PSQI		Baseline, 4 weeks and 8 weeks
Secondary	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
Secondary	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
Secondary	GAD-7		Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
Secondary	QIDS-SR		Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
Secondary	MADRS		Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks