6 Weeks Right-Amygdala TIS for Depression

NCT ID: NCT07059143

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-27
• Study Completion Date: 2026-12-31

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 (MDD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Amygdala TI

18 sessions will be delivered in 6 weeks: 5 sessions per week for the first two weeks and 2 sessions per week for the following four weeks

Group Type: EXPERIMENTAL

Nervio-X

Intervention Type: DEVICE

An 8-channel TIS device developed by NEURODOME Corporation.

Controlled TI

18 sessions will be delivered in 6 weeks: 5 sessions per week for the first two weeks and 2 sessions per week for the following four weeks

Group Type: SHAM_COMPARATOR

Nervio-X

Intervention Type: DEVICE

An 8-channel TIS device developed by NEURODOME Corporation.

Interventions

Nervio-X

An 8-channel TIS device developed by NEURODOME Corporation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age : 18 to 60 years (inclusive), any gender.
• Diagnosis : Major depressive episode diagnosed by study physicians according to the Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5), with no restriction on first-onset or recurrent episodes.
• Symptom Severity : 17-item Hamilton Depression Rating Scale (HAMD-17) score ≥ 17 at screening.
• Treatment Stability : Antidepressant regimen must remain unchanged from 30 days prior to signing informed consent through the study duration. Patients using >2 antidepressants or combinations of antidepressant(s) + augmenting agent(s) must be adjusted to ≤2 agents* ≥1 week prior to enrollment.
• Cognitive Capacity : Sufficient literacy and comprehension skills to complete study assessments.
• Compliance : Investigator-confirmed understanding of study objectives/procedures, protocol compliance, and provision of written informed consent.

Exclusion Criteria

• Comorbidities : Major psychiatric disorders (e.g., schizophrenia, bipolar disorder) Significant neurological conditions (e.g., traumatic brain injury, post-neurosurgical status)
• Medical Devices : Intracranial/cardiac metallic implants or electronic medical devices (e.g., pacemakers, deep brain stimulation systems)
• Recent Interventions : Electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or other neuromodulation therapies within 30 days prior to enrollment
• Clinical Instability : Acute suicidality (e.g., active suicidal ideation with intent) Inability to complete study follow-up per investigator judgment
• Concurrent Trials : Participation in other interventional clinical studies during the trial period
• Reproductive Status : Pregnancy, lactation, or plans for conception during the trial
• Suicide Risk : Score ≥3 on Item 3 of the 17-item Hamilton Depression Rating Scale (HAMD-17)
• Any condition deemed to compromise subject safety or study validity per clinical evaluation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

ZHANG CHENCHEHG

Clinical Neuroscience Center Deputy Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yiru Fang, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

The Affiliated Brain Hospital Of Guangzhou Medical University

Guangdong, , China

Ruijin Hospital

Shanghai, , China

Anding Hospital (Mental Health Center of Tianjin Medical University)

Tianjin, , China

Countries

China

Other Identifiers

2025LLSD212-001

Identifier Type: -

Identifier Source: org_study_id