Amygdala MRI-TIS for Depression

Last updated: June 11, 2024
Sponsor: Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Depression (Major/severe)

Mood Disorders

Treatment

Nervio-X

Clinical Study ID

NCT06461260
PDJW-2024-001CSA
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andStatistical Manual of Mental Disorders (DSM-5);

  • HAMD-17 score of 17 or higher;

  • Participants must not have changed their antidepressant medication regimen from 30days prior to signing the informed consent form through the duration of theexperiment;

  • Eligible individuals or their authorized representatives must demonstrate, asassessed by the study physician, a comprehensive understanding of the study'sobjectives and procedures, be capable of adhering to the requirements set forth inthe study protocol, and provide their signature on the informed consent form.

Exclusion

Exclusion Criteria:

  • Eligible participants must not have a history of psychiatric or neurologicaldisorders, as judged by the investigator, which may impact the evaluation of thestudy'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 metalliccardiac implants;

  • Participants must not have a diagnosis of organic brain disease, nor a history ofsignificant cranial trauma or neurosurgical intervention;

  • Participants received electroconvulsive therapy or other physical therapies (such astranscranial magnetic stimulation therapy);

  • The researcher evaluated the individual's mental state and determined it to presenta 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 deemsunsuitable for the intervention being studied

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Nervio-X
Phase:
Study Start date:
May 27, 2024
Estimated Completion Date:
April 28, 2025

Connect with a study center

  • Shanghai Pudong New Area Mental Health Center

    Shanghai, Shanghai
    China

    Active - Recruiting

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