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OpenTrials
Completed

NCT Number: NCT06477276

Amygdala TIS for 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nervio-X

Device

An 8-channel TIS device developed by NEURODOME Corporation.

Primary outcomes

  1. Quick Inventory of Depressive Symptomatology - Self-Report (16-item version)

    Time frame: 4 weeks

Secondary outcomes

  1. Hamilton Depression Rating Scale (17-item version)

    Time frame: Baseline, 1 week, 4 weeks and 8 weeks

  2. Quick Inventory of Depressive Symptomatology - Self-Report (16-item version)

    Time frame: Baseline, 1 week and 8 weeks

  3. Snaith-Hamilton Pleasure Scale

    Time frame: Baseline, 1 week, 4 weeks and 8 weeks

    The SHAPS is a questionnaire that used to measure the severity of anhedonia, a common symptom in various mental health conditions.

  4. Hamilton Anxiety Rating Scale

    Time frame: Baseline, 4 weeks and 8 weeks

  5. Pittsburgh Sleep Quality Index

    Time frame: Baseline, 4 weeks and 8 weeks

  6. 36-Item Short Form Health Survey

    Time frame: Baseline and 8 weeks

  7. World Health Organization Quality of Life Assessment - Brief Version

    Time frame: Baseline and 8 weeks

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Shanghai East Hospital
  • Tianjin Anding Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2024
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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