Amygdala TIS for Depression

Last updated: June 16, 2025
Sponsor: Ruijin Hospital
Overall Status: Completed

Phase

N/A

Condition

Depression

Depression (Major/severe)

Affective Disorders

Treatment

Nervio-X

Clinical Study ID

NCT06477276
2024LLSD160-001
  • Ages 18-65
  • All Genders

Study Summary

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.

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 disorders such asschizophrenia, 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: 92
Treatment Group(s): 1
Primary Treatment: Nervio-X
Phase:
Study Start date:
July 24, 2024
Estimated Completion Date:
May 01, 2025

Connect with a study center

  • Ruijin Hospital

    Shanghai, Shanghai 200025
    China

    Site Not Available

  • Shanghai East Hospital

    Shanghai,
    China

    Site Not Available

  • Tianjin Anding Hospital (Mental Health Center of Tianjin Medical University)

    Tianjin,
    China

    Site Not Available

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