Depressive symptoms
Conditions
Interventions
The AI-TBS pseudo-stimulation group:Maintain pseudo stimulus
The aiTBS stimulation group:Active stimulation
Sponsors
Ningbo University Affiliated Kangning Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18–65 years, right-handed; 2. Meet the diagnostic criteria for depression according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); 3. HAMD-24 total score >= 20 points; 4. Classified as moderate to severe treatment-resistant according to the Maudsley Staging Method (MSM), with a score higher than 6; 5. Physical examination, medical history, vital signs, routine blood, urine, and stool tests, liver and kidney function, electrolytes, ECG, and EEG are all normal; 6. Fully understand the safety of TMS, willing to actively cooperate with treatment, and informed consent signed by both the patient and their family.
Exclusion criteria
Exclusion criteria: 1. History of severe physical illness and depression caused by other psychoactive substances or non-dependent substances; 2. Patients with metal or electronic devices implanted in the body, such as intracranial metal foreign bodies, cochlear implants, pacemakers, and stents; 3. At risk of epileptic seizures, with a history of brain disease, head trauma, alcohol abuse, abnormal EEG, evidence of brain structural abnormalities on MRI, or a family history of epilepsy; 4. Presence of psychotic symptoms requiring concurrent antipsychotic medication; 5. Received ECT, TMS, or other tES treatments, or systemic psychotherapy within the 3 months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of depressive symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| Motor behavior ability;Anxiety, insomnia, suicide, and other clinical symptoms;Brain region activation, functional connectivity, cortical plasticity, etc; | — |
Countries
China
Contacts
Public ContactDongsheng Zhou
Ningbo University Affiliated Kangning Hospital
Outcome results
None listed