Amygdala TIS for Depression

NCT ID: NCT06477276

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-24
• Study Completion Date: 2025-05-01

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

Study Design

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

Study Groups

Amygdala TI

5 sessions will be delivered in 3 weeks

Group Type: EXPERIMENTAL

Nervio-X

Intervention Type: DEVICE

An 8-channel TIS device developed by NEURODOME Corporation.

Controlled TI

5 sessions will be delivered in 3 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Anding Hospital

OTHER

Sponsor Role: collaborator

Shanghai East Hospital

OTHER

Sponsor Role: collaborator

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

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Shanghai East Hospital

Shanghai, , China

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

Tianjin, , China

Countries

China

Other Identifiers

2024LLSD160-001

Identifier Type: -

Identifier Source: org_study_id