Amygdala and dLPFC MRI-TIS for Depression in Adolescents

NCT06452849 | Recruiting

• 1 other identifier: PDJW-2024-001CSB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 adolescent depressive disorders.

Conditions

Major Depressive Disorder

Keywords

Adolescents; Deep Brain Stimulation; Major Depressive Disorder; Temporal Interference; Amygdala

Outcome Measures

Primary Outcomes (11)

• HAMD-17

  Baseline, after treatment, 1 week, 4 weeks and 8 weeks

• HAMA

  Baseline, after treatment, 1 week, 4 weeks and 8 weeks

• MADRS

  Baseline, after treatment, 1 week, 4 weeks and 8 weeks

• PHQ-A

  Baseline, after treatment, 1 week, 4 weeks and 8 weeks

• GAD-7

  Baseline, after treatment, 1 week, 4 weeks and 8 weeks

• SHAPS

  Baseline, 4 weeks and 8 weeks

• PSQI

  Baseline, 4 weeks and 8 weeks

• SF-36

  Baseline and 8 weeks

• WHOQOL-BREF

  Baseline and 8 weeks

• ARI

  Baseline and 8 weeks

• OSI

  For use when the patient exhibits self-harming behavior

  Baseline, 4 weeks and 8 weeks

Study Arms (2)

Amygdala TI

EXPERIMENTAL

Right amygdala Temporal Interference (TI) stimulation with 100 frequency difference, 20 minutes per day for 5 days.

Device: Nervio-X

dLPFC TI

EXPERIMENTAL

L\_dLPFC TI Temporal Interference (TI) stimulation with 10 frequency difference, 20 minutes per day for 5 days.

Device: Nervio-X

Interventions

Nervio-X DEVICE

An 8-channel TIS device developed by NEURODOME Corporation.

Amygdala TI; dLPFC TI

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Pudong New Area Mental Health Center

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

JINGJING HUANG, MD PhD

CONTACT

021-68306699*1222; jjhuang_att@163.com

Chencheng Zhang, MD PhD

CONTACT

18217122884; i@cczhang.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: May 27, 2024
• Primary Completion: April 28, 2025
• Study Completion: April 28, 2025
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)