6 Weeks Right-Amygdala TIS for Depression

Shanghai Jiao Tong University

Status

Invitation-only

Conditions

Major Depressive Disorder (MDD)

Treatments

Device: Nervio-X

Study type

Interventional

Funder types

Other

Identifiers

NCT07059143

2025LLSD212-001

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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