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The investigators aim to investigate whether the intervention effect of pBFS-guided rTMS therapy targeting DLPFC is superior to the intervention effect of the traditional "5 cm-rule" guided rTMS therapy in patients with depressive disorders.
After being informed about the study and potential risks. All patients giving written informed consent will undergo a screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a blind manner in a 1:1 ratio to the pBFS group, or 5-cm rule group. Then all participants will undergo a 21-day rTMS modulation and 7-day, 14-day, and 45-day post-treatment follow-up visits. Participants will not take any other treatment during the intervention and the 7-day and 14-day post-treatment visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pBFS rTMS | Experimental | 3 sessions of active rTMS would be delivered to the pBFS-guided left DLPFC daily, with a session of 1800 pulse. |
|
| 5-cm rTMS | Active Comparator | 3 sessions of active rTMS would be delivered to the "5-cm rule" guided left DLPFC daily, with a session of 1800 pulse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pBFS rTMS | Device | Participants will receive 3 sessions per day of 1800 pulses per session, lasting for 21 days. Individualized targets will be generated using the pBFS method. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores | The MADRS is a validated instrument stratifying the severity of depressive episodes in adults. The MADRS has an overall score ranging from 0 (no depression) to 60 (worst depression). | Baseline and Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| changes in MADRS | The MADRS is a validated instrument stratifying the severity of depressive episodes in adults. The MADRS has an overall score ranging from 0 (no depression) to 60 (worst depression). | Baseline, Day 7, Day 14, Day 21 (immediate post-treatment), 7-day post-treatment, 14-day post-treatment, 45-day post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meiling Li, Ph.D. | Contact | 010-80726688 | meilingli@cpl.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hesheng Liu, Ph.D. | Changping Laboratory | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Mental Health Center | Recruiting | Baoding | Hebei | China |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| 5-cm rTMS | Device | Participants will receive 3 sessions per day of 1800 pulses per session, lasting for 21 days. Individualized targets will be localized by "5-cm rule". |
|
| changes in HAMD |
The Hamilton Depression Rating Scale (HAMD) is the most widely used clinician-administered depression assessment scale. The HAMD-17 version consists of 17 items,and has an overall score ranging from 0 (no depression) to 52 (worst depression). Higher scores represent higher depression severity. |
| Baseline, Day 7, Day 14, Day 21 (immediate post-treatment), 7-day post-treatment, 14-day post-treatment, 45-day post-treatment |
| cognitive change in Digit Symbol Substitution Test (DSST) | Cognitive scores are measured using Chinese brief cognitive test (C-BCT), the DSST equires a subject to match symbols to numbers according to a key located on the top of the page | Baseline, Day 21 (Immediate Post-treatment) |
| cognitive change in continuous performance test (CPT) | CPT from the C-BCT measures a person's sustained and selective attention | Baseline, Day 21 (Immediate Post-treatment) |
| cognitive change in Trail-Making Test (TMT) | The TMT test from the C-BCT can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning | Baseline, Day 21 (Immediate Post-treatment) |
| cognitive change in Digit Span Test (DST) | DST from the C-BCT is a measure of verbal short term and working memory that can be used in two formats, Forward Digit Span and Reverse Digit Span | Baseline, Day 21 (Immediate Post-treatment) |
| Henan Mental Hospital | Recruiting | Xinxiang | Henan | China |
|
| Tianjin general hospital | Not yet recruiting | Tianjin | Tianjin Municipality | China |
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| Hangzhou Seventh People's Hospital | Not yet recruiting | Hanzhou | Zhejiang | China |
|