Clinical trial NCT06461260: Amygdala MRI-TIS for Depression
Official title: Safety, Efficacy and Neuroimaging Mechanisms of Amygdala Temporal Interference Stimulation Therapy for Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Deep Brain Stimulation
TI stimulation
Lead sponsor: Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
First posted: 2024-06-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study utilizes a non-invasive deep brain stimulation (temporal interference, TI) technique primarily targeting the amygdala to preliminarily explore the clinical efficacy and potential mechanisms of MRI-compatible TI technology in regulating the amygdala in depressive disorders, providing a more comprehensive basis for the application of TI technology.


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

Primary outcomes:
measure: HAMD-17
timeFrame: Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
Secondary outcomes:
measure: HAMA
timeFrame: Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
measure: SHAPS
timeFrame: Baseline, 4 weeks and 8 weeks
measure: SF-36
timeFrame: Baseline and 8 weeks
measure: WHOQOL-BREF
timeFrame: Baseline and 8 weeks
measure: PSQI
timeFrame: Baseline, 4 weeks and 8 weeks
measure: THINC-it®
timeFrame: Baseline, treatment completion day and 8 weeks
measure: Blood sample
timeFrame: Baseline, 4 weeks
measure: GAD-7
timeFrame: Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
measure: QIDS-SR
timeFrame: Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
measure: MADRS
timeFrame: Baseline, treatment completion day, 1 week, 4 weeks and 8 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pudong New Area Mental Health Center
state: Shanghai
Study officials:
References: