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Intermittent theta-burst stimulation (iTBS), a variant of repetitive transcranial magnetic stimulation (rTMS), is a well-documented treatment for depression. The aim of this study is to evaluate the effectiveness of an accelerated iTBS protocol (1W-AiTBS) in routine clinical practice. In the accelerated protocol, patients receive 600 pulses per session, for a total of 30 sessions administered over 5-14 treatment days. Patient inclusion will take place over a maximum period of 1.5 years, with a maximum sample size of 150 patients. The target sample size is at least 36 patients. Patients will complete self-rating questionnaires at screening, before and after treatment, and at 6 weeks, 12 weeks, and 6 months from the first day of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1W-AiTBS | Magnetic pulses of 80% of visual motor threshold applied in triplets of 50 Hz bursts, repeated at 5 Hz; 2 seconds on and 8 seconds off; 600 pulses per session; total duration of 3 min 20 s over the left DLPFC (F3), given in a maximum of 8 sessions per day (>15 min interval), total of 30 treatments on total of 10 week days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iTBS (intermittent theta-burst stimulation) | Device | The iTBS treatment is a type of rTMS (repetitive transcranial magnetic stimulation), delivered with MagPro R30 stimulator and a conventional cool-B65 coil. The iTBS treatment is applied to over the dorsolateral prefrontal cortex using a standardized measuring of the anatomical landmark F3 from the 10-20 positioning system. The coil is positioned with the handle at in a 45 degree angle from the midline. The centre of the butterfly is placed towards the patient head. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in MADRS-S from baseline to six weeks after first iTBS treatment | The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in MADRS-S from baseline to after last iTBS treatment | The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms | 2 weeks |
| Difference in MADRS-S from baseline to twelve weeks after first iTBS treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients referred for AiTBS treatment at participating study sites will be invited to participate in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melker Hagsäter, MD, MSc, PhD, PhD | Contact | +46 3039 8000 | melker.hagsater@vgregion.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Recruiting | Gothenburg | Sweden |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms |
| 12 weeks |
| Difference in MADRS-S from baseline to six months after first iTBS treatment | The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms | 6 months |
| Difference in SDS from baseline to twelve weeks after first iTBS treatment | The Sheehan Disability Scale (SDS) is a self-rating assessment (0-30 points), where a higher score indicates more pronounced functional impairment | 12 weeks |
| Difference in SDS from baseline to six months after first iTBS treatment | The Sheehan Disability Scale (SDS) is a self-rating assessment (0-30 points), where a higher score indicates more pronounced functional impairment | 6 months |
| Difference in EQ-VAS from baseline to after last iTBS treatment | The EQ-5D visual analogue scale (EQ-VAS) is a self-rating assessment (VAS 0-100 points), where a higher (VAS) score indicates a higher health-related quality of life | 2 weeks |
| Difference in EQ-VAS from baseline to six weeks after first iTBS treatment | The EQ-5D visual analogue scale (EQ-VAS) is a self-rating assessment (VAS 0-100 points), where a higher (VAS) score indicates a higher health-related quality of life | 6 weeks |
| Difference in EQ-VAS from baseline to twelve weeks after first iTBS treatment | The EQ-5D visual analogue scale (EQ-VAS) is a self-rating assessment (VAS 0-100 points), where a higher (VAS) score indicates a higher health-related quality of life | 12 weeks |
| Difference in EQ-VAS from baseline to six months after first iTBS treatment | The EQ-5D visual analogue scale (EQ-VAS) is a self-rating assessment (VAS 0-100 points), where a higher (VAS) score indicates a higher health-related quality of life | 6 months |
| Difference in reported potential side effects from baseline to after last iTBS treatment | A patient-reported form including the most commonly reported side effects of rTMS. | 2 weeks |
| Difference in reported potential side effects from baseline to six weeks after first iTBS treatment | A patient-reported form including the most commonly reported side effects of rTMS. | 6 weeks |
| Difference in reported potential side effects from baseline to twelve weeks after first iTBS treatment | A patient-reported form including the most commonly reported side effects of rTMS. | 12 weeks |
| Difference in reported potential side effects from baseline to six months after first iTBS treatment | A patient-reported form including the most commonly reported side effects of rTMS. | 6 months |
| rTMS associated pain experience | A patient-reported form rating experience of pain (scale 1 to 10) during rTMS treatment. Performed after last treatment series | 2 weeks |
| Number of patients in remission after last iTBS treatment | A patient with a MADRS-S score of < 10 is considered to be in remission | 2 weeks |
| Number of patients in remission six weeks after first iTBS treatment | A patient with a MADRS-S score of < 10 is considered to be in remission | 6 weeks |
| Number of patients in remission twelve weeks after first iTBS treatment | A patient with a MADRS-S score of < 10 is considered to be in remission | 12 weeks |
| Number of patients in remission six months after first iTBS treatment | A patient with a MADRS-S score of < 10 is considered to be in remission | 6 months |
| Kungälv Hospital, Kungälv | Recruiting | Kungälv | Sweden |
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| Central Hospital Växjö | Recruiting | Vaxjo | Sweden |
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