Major Depressive Disorder
Conditions
Keywords
Deep Brain Stimulation, Non-invasive, TI, Amygdala, Temporal Interference
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.
Interventions
DEVICENervio-X
An 8-channel TIS device developed by NEURODOME Corporation.
Sponsors
Tianjin Anding Hospital
Shanghai East Hospital
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quick Inventory of Depressive Symptomatology - Self-Report (16-item version) | 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quick Inventory of Depressive Symptomatology - Self-Report (16-item version) | Baseline, 1 week and 8 weeks | — |
| Snaith-Hamilton Pleasure Scale | Baseline, 1 week, 4 weeks and 8 weeks | The SHAPS is a questionnaire that used to measure the severity of anhedonia, a common symptom in various mental health conditions. |
| Hamilton Anxiety Rating Scale | Baseline, 4 weeks and 8 weeks | — |
| Hamilton Depression Rating Scale (17-item version) | Baseline, 1 week, 4 weeks and 8 weeks | — |
| 36-Item Short Form Health Survey | Baseline and 8 weeks | — |
| World Health Organization Quality of Life Assessment - Brief Version | Baseline and 8 weeks | — |
| Pittsburgh Sleep Quality Index | Baseline, 4 weeks and 8 weeks | — |
Countries
China
Outcome results
None listed