Depression
Conditions
Keywords
iTBS, rTMS, depression
Brief summary
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.
Interventions
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.
Sponsors
Vastra Gotaland Region
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of depression verified through a Mini International Neuropsychiatric Interview (M.I.N.I.) * provision of signed informed consent form * indication for TMS is depression
Exclusion criteria
* conductive ferromagnetic or other metals implanted in the head or within 30 cm of the treatment coil * implanted device that is activated or controlled in any way by physiological signals * implanted mediation pumps * intracardiac lines, even when removed * any condition that seriously increases the risk of non-compliance or loss of follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in MADRS-S from baseline to six weeks after first iTBS treatment | 6 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in MADRS-S from baseline to after last iTBS treatment | 2 weeks | 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 |
| Difference in MADRS-S from baseline to twelve weeks after first iTBS treatment | 12 weeks | 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 |
| Difference in MADRS-S from baseline to six months after first iTBS treatment | 6 months | 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 |
| Difference in SDS from baseline to twelve weeks after first iTBS treatment | 12 weeks | The Sheehan Disability Scale (SDS) is a self-rating assessment (0-30 points), where a higher score indicates more pronounced functional impairment |
| Difference in SDS from baseline to six months after first iTBS treatment | 6 months | The Sheehan Disability Scale (SDS) is a self-rating assessment (0-30 points), where a higher score indicates more pronounced functional impairment |
| Difference in EQ-VAS from baseline to after last iTBS treatment | 2 weeks | 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 |
| Difference in EQ-VAS from baseline to six weeks after first iTBS treatment | 6 weeks | 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 |
| Difference in EQ-VAS from baseline to twelve weeks after first iTBS treatment | 12 weeks | 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 |
| Difference in EQ-VAS from baseline to six months after first iTBS treatment | 6 months | 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 |
| Difference in reported potential side effects from baseline to after last iTBS treatment | 2 weeks | A patient-reported form including the most commonly reported side effects of rTMS. |
| Difference in reported potential side effects from baseline to six weeks after first iTBS treatment | 6 weeks | A patient-reported form including the most commonly reported side effects of rTMS. |
| Difference in reported potential side effects from baseline to twelve weeks after first iTBS treatment | 12 weeks | A patient-reported form including the most commonly reported side effects of rTMS. |
| Difference in reported potential side effects from baseline to six months after first iTBS treatment | 6 months | A patient-reported form including the most commonly reported side effects of rTMS. |
| rTMS associated pain experience | 2 weeks | A patient-reported form rating experience of pain (scale 1 to 10) during rTMS treatment. Performed after last treatment series |
| Number of patients in remission after last iTBS treatment | 2 weeks | A patient with a MADRS-S score of \< 10 is considered to be in remission |
| Number of patients in remission six weeks after first iTBS treatment | 6 weeks | A patient with a MADRS-S score of \< 10 is considered to be in remission |
| Number of patients in remission twelve weeks after first iTBS treatment | 12 weeks | A patient with a MADRS-S score of \< 10 is considered to be in remission |
| Number of patients in remission six months after first iTBS treatment | 6 months | A patient with a MADRS-S score of \< 10 is considered to be in remission |
Countries
Sweden
Contacts
CONTACTMelker Hagsäter, MD, MSc, PhD, PhD
Outcome results
None listed