Non-invasive brain stimulation for treating depression

Safety, Efficacy and Neuroimaging Mechanisms of Amygdala Temporal Interference Stimulation Therapy for Depression

This study is testing a new non-invasive brain stimulation method to see if it can help people with major depression feel better by targeting a specific area in the brain.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University (other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06461260 on ClinicalTrials.gov

What this trial studies

This study explores the use of a non-invasive deep brain stimulation technique called temporal interference (TI) to target the amygdala in individuals with major depressive disorder. By utilizing MRI-compatible TI technology, the study aims to assess its clinical efficacy and understand the underlying mechanisms involved in regulating the amygdala. Participants will undergo treatment with the Nervio-X device while their responses to the intervention are monitored. The goal is to provide a comprehensive basis for the future application of TI technology in treating depression.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 who have been diagnosed with major depressive disorder and meet specific clinical criteria.

Not a fit: Patients with a history of psychiatric or neurological disorders that could affect the study's evaluation may not benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could offer a novel and effective treatment option for patients suffering from major depressive disorder.

How similar studies have performed: While the use of deep brain stimulation techniques has been explored in other studies, the specific application of temporal interference targeting the amygdala is relatively novel.

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 or neurological disorders, 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

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Pudong New Area Mental Health Center — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Jingjing HUANG, MD PhD

Conditions: Major Depressive Disorder, Deep Brain Stimulation, TI stimulation