6 Weeks Right-Amygdala TIS for Depression

NCT07059143 | Completed

• 1 other identifier: 2025LLSD212-001
• Study Type: interventional
• Target: 38
• 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 (MDD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (17-item version)

  The Hamilton Depression Rating Scale is a widely utilized clinician-administered instrument for assessing depression severity, consisting of 17 items that evaluate core depressive symptoms. Total scores range from 0-52, with established cutoff points: 0-7 (no depression/remission), 8-13 (mild depression), 14-18 (moderate depression), 19-22 (severe depression), and ≥23 (very severe depression). The HAM-D17 demonstrates good internal consistency reliability with Cronbach's alpha values ranging from 0.747 to 0.829.

  Baseline, 6 weeks

Secondary Outcomes (8)

• Hamilton Depression Rating Scale (17-item version)

  Baseline, 1 week, 2 weeks, 6 weeks, 10 weeks

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

  Baseline, 1 week, 2 weeks, 6weeks, 10 weeks

• THINC-it®: An Integrated Tool for Cognitive Dysfunction Screening

  Baseline, 2 weeks, 6 weeks, 10 weeks

• Snaith-Hamilton Pleasure Scale (SHAPS)

  Baseline, 1 week, 2 weeks, 6 weeks, 10 weeks

• Hamilton Anxiety Rating Scale (HAMA)

  Baseline, 1 week, 2 weeks, 6 weeks, 10 weeks

Study Arms (2)

Amygdala TI

EXPERIMENTAL

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

Device: Nervio-X

Controlled TI

SHAM COMPARATOR

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

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 - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (3)

The Affiliated Brain Hospital Of Guangzhou Medical University

Guangdong, China

Location

Ruijin Hospital

Shanghai, China

Location

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, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Neuroscience Center Deputy Director

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: May 27, 2025
• Primary Completion: May 29, 2026
• Study Completion: July 8, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)