Depression, anxiety, insomnia, loss of pleasure, etc
Conditions
Interventions
40Hz frequency difference tTIS true stimulation group:(Group with frequency difference of 40 Hz + tTIS): The two applied frequencies are 2000 Hz and 2040 Hz, with a stimulation duration of 30 minutes
The TIS pseudo-stimulation group:(Group with sham tTIS): A frequency difference of either 40 Hz or 130 Hz was applied to half of the participants each, with a duration of 1 minute (30 seconds ramp-up,
130Hz frequency difference tTIS true stimulation group:(Group with frequency difference of 130 Hz + tTIS): The two applied frequencies are 2000 Hz and 2130 Hz, with a stimulation duration of 30 minute
Sponsors
Affiliated Kangning Hospital of Ningbo University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years, right-handed; 2. Meeting the diagnostic criteria for depression in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); 3.Total score of Hamilton Depression Rating Scale-24 (HAMD-24) >=20; 4.According to the Mozley Staging Method (MSM), it is classified as moderate to severe treatment-resistant, with a score higher than 6; 5.Normal results in physical examination, medical history, vital signs, routine blood/urine/stool tests, liver and kidney function, electrolytes, electrocardiogram (ECG), electroencephalogram (EEG), and other indicators; 6.Willing to actively cooperate with treatment after fully understanding the safety of transcranial temporal interference stimulation (tTIS), and signing the informed consent form along with their family members. 7.Both have taken selective serotonin reuptake inhibitor SSRI) drugs and have been on a stable dose of antidepressants for at least 2 weeks without effect
Exclusion criteria
Exclusion criteria: 1.Has a history of severe physical illness and depression caused by psychoactive substances and non-substance-dependent substances; 2.Patients who have metal or electronic devices implanted in their bodies, such as intracranial metal foreign bodies, cochlear implants, cardiac pacemakers, and metal stents, etc. 3.There is a risk of epilepsy seizure. The patient has a history of brain disorders, head trauma, alcohol abuse, abnormal electroencephalogram, MRI evidence of brain structure abnormalities, or a family history of epilepsy. 4.Those with psychotic symptoms who require combined use of antipsychotic drugs; 5.Individuals who have received other physical therapies such as ECT, TMS, or tES, as well as systematic psychological therapy, within the two months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scales (including: 1. Hamilton Depression Rating Scale (HAMD-24); 2. Hamilton Anxiety Rating Scale (HAMA); 3. Montgomery-?sberg Depression Rating Scale (MADRS); 4. Pittsburgh Sleep Quality Index (PSQI); 5. Snaith-Hamilton Pleasure Scale (SHAPS); 6. Beck Scale for Suicide Ideation, Chinese Version (BSI-CV); 7. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS); 8. Behavioral Inhibition/Activation Systems Scale (BIS/BAS); 9. Temporal Experience of Pleasure Scale (TEPS); 10.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Electrophysiological indicators (including MRI, EEG, near-infrared spectroscopy, and other neurophysiological measures).; | — |
Countries
China
Contacts
Public ContactDongsheng Zhou
Affiliated Kangning Hospital of Ningbo University
Outcome results
None listed