Amygdala TIS for Depression

NCT06477276 | Completed

• 1 other identifier: 2024LLSD160-001
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Major Depressive Disorder

Keywords

Deep Brain Stimulation; Non-invasive; TI; Amygdala; Temporal Interference

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Secondary Outcomes (7)

• Hamilton Depression Rating Scale (17-item version)

  Baseline, 1 week, 4 weeks and 8 weeks

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

  Baseline, 1 week and 8 weeks

• Snaith-Hamilton Pleasure Scale

  Baseline, 1 week, 4 weeks and 8 weeks

• Hamilton Anxiety Rating Scale

  Baseline, 4 weeks and 8 weeks

• Pittsburgh Sleep Quality Index

  Baseline, 4 weeks and 8 weeks

Study Arms (2)

Amygdala TI

EXPERIMENTAL

5 sessions will be delivered in 3 weeks

Device: Nervio-X

Controlled TI

SHAM COMPARATOR

5 sessions will be delivered in 3 weeks

Device: Nervio-X

Interventions

Nervio-X DEVICE

An 8-channel TIS device developed by NEURODOME Corporation.

Amygdala TI; Controlled TI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Tianjin Anding Hospital: collaborator
• Shanghai East Hospital: collaborator

Study Sites (3)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Shanghai East Hospital

Shanghai, China

Location

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

Tianjin, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Yiru Fang, MD PhD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

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: Clinical Neuroscience Center Deputy Director

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 27, 2024
• Study Start: July 24, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)