Temporal Interference Stimulation of Amygdala and dLPFC: A Randomized Controlled Trial for Adolescent Depression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- GAD-7
Study Overview
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 adolescent depressive disorders.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 14 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants must be aged between 14 and 18, 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
Outcomes
Primary Outcomes
GAD-7
Time Frame: Baseline, after treatment, 1 week, 4 weeks and 8 weeks
ARI
Time Frame: Baseline and 8 weeks
MADRS
Time Frame: Baseline, after treatment, 1 week, 4 weeks and 8 weeks
PHQ-A
Time Frame: Baseline, after treatment, 1 week, 4 weeks and 8 weeks
SF-36
Time Frame: Baseline and 8 weeks
SHAPS
Time Frame: Baseline, 4 weeks and 8 weeks
PSQI
Time Frame: Baseline, 4 weeks and 8 weeks
WHOQOL-BREF
Time Frame: Baseline and 8 weeks
HAMD-17
Time Frame: Baseline, after treatment, 1 week, 4 weeks and 8 weeks
HAMA
Time Frame: Baseline, after treatment, 1 week, 4 weeks and 8 weeks
OSI
Time Frame: Baseline, 4 weeks and 8 weeks
For use when the patient exhibits self-harming behavior
Secondary Outcomes
No secondary outcomes reported
Investigators
huangjingjing
Chief Physician
Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University