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The aim of this study was to explore the efficacy and safety of temporal interference stimulation to improve bipolar depression, as well as to explore the corresponding neuroimaging mechanisms using magnetic resonance and electroencephalogram to provide novel intervention protocols and objective indicators of efficacy prediction for depressive episodes in bipolar disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temporal Interference Stimulation | Active Comparator |
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| Sham Temporal Interference Stimulation | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temporal Interference Stimulation | Device | A non-invasive, non-invasive method of deep brain electrical stimulation utilizing high-frequency electric field interactions to produce a low-frequency envelope to modulate neural activity. |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale（MADRS） | Montgomery-Asberg Depression Rating Scale (MADRS) is used to reflect the effect of antidepressant treatment and monitor the change of patients' condition. The scale is a separate scale, and the score should be based on clinical interviews. The symptoms should be asked from broad to detailed, so as to accurately score the severity. The rater must determine whether the score is on the defined score values (0,2,4,6) or between these scores (1,3,5), according to clinical practice. MADRS has a minimum value of 0 and a maximum value of 60, with larger scores representing poorer results. | * "Baseline" * "Day 5" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation" |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Scale（HAMD-17) | The Hamilton Depression Scale（HAMD-17) was used to assess the extent of the patient's depressive episodes, with higher scores representing more severe depression, and this scale was used to monitor the patient's improvement in depression before and after treatment. HAMD-17 has a minimum value of 0 and a maximum value of 52, with larger scores representing poorer results. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shaohua Hu, PhD | Contact | 0571-87232984 | dorhushaohua@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, First Affiliated Hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Sham Temporal Interference Stimulation | Device | The same machine was used as the temporal Interferenc real stimulus, with current creep only 20 seconds before stimulus onset to simulate the real stimulus sensation. |
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| * "Baseline" * "Day 5" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation" |
| Hamilton Anxiety Scale（HAMA） | The Hamilton Anxiety Scale is primarily used for the assessment of anxiety levels, and has 14 items, each of which has a 0-4 scale, with anxiety possible above a score of 7. HAMA has a minimum value of 0 and a maximum value of 56, with larger scores representing poorer results. The higher the score, the more severe the anxiety. | * "Baseline" * "Day 5" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation" |
| Young Mania Rating Scale（YMRS） | The Young Mania Rating Scale is mainly used to assess the manic symptoms of the subjects before and after the treatment, there are 11 items, each symptom has a working scale, divided into 5 levels, the level score of each item is different, most of them are 0-4, in which the 5th, 6th, 8th and 9th items are scored as 0, 2, 4, 6, 8, and the higher the total score of the subject the more serious the degree of mania. YMRS has a minimum value of 0 and a maximum value of 60, with larger scores representing poorer results. | * "Baseline" * "Day 5" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation" |
| Snaith-Hamilton Pleasure Scale（SHAPS） | The Snaith-Hamilton Pleasure Scale is a self-report scale that assesses the degree of the subject's pleasure deficit; the higher the score, the more severe their pleasure deficit. The scale was used to assess the degree of improvement in the patients' pleasure deficit before and after treatment. The minimum value of SHAPS is 14 and the maximum value is 56, with larger scores representing poorer results. | * "Baseline" * "Day 5" * "1 week after the end of temporal interference stimulation" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation" |
| Temporal Experience of Pleasure Scale (TEPS) | The Temporal Experience of Pleasure Scale (TEPS) is a self-report scale that assesses an individual's anticipation and experience of future pleasure, with higher scores suggesting a stronger experience of pleasure. The scale was used to evaluate the degree of improvement of pleasure deficit before and after treatment. The TEPS scale has a maximum value of 120 and a minimum value of 20. Lower scores indicate higher levels of pleasure deficit, while higher scores indicate higher levels of pleasure experience. | * "Baseline" * "Day 5" * "1 week after the end of temporal interference stimulation" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation" |
| Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) | The Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) is a self-report scale with 16 items that is primarily used to assess patients' depressive symptoms. The QIDS-SR scale has a minimum value of 0 and a maximum value of 27, with higher scores indicating poorer results. | * "Baseline" * "Day 1-5" * "1 week after the end of temporal interference stimulation" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation" |
| Self-Rating Depression Scale (SDS) | The Self-Rating Depression Scale (SDS), a 20-item, 4-point scale, is used to assess the severity of an individual's depressive symptoms. The SDS scale has a maximum value of 100 and a minimum value of 25, with larger scores representing poorer results. | * "Baseline" * "Day 5" * "1 week after the end of temporal interference stimulation" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation" |
| Self-Rating Anxiety Scale (SAS) | The Self-Rating Anxiety Scale (SAS) contains 20 items reflecting subjective feelings of anxiety, and each item is rated on a four-point scale according to the frequency of the symptom, with 15 positive ratings and 5 negative ratings (marked with an asterisk *), which allows the scale to rate the severity of anxiety symptoms and their change in treatment. The SAS scale has a maximum value of 100 and a minimum value of 25, with larger scores representing poorer results. | * "Baseline" * "Day 5" * "1 week after the end of temporal interference stimulation" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation" |
| THINC-integrated tool (THINC-it) | THINC-it tool for assessing cognitive function changes in patients. | * "Baseline" * "Day 5" * "2 weeks after the end of temporal interference stimulation" * "4 weeks after the end of temporal interference stimulation" |