The antidepressant effect of intermittent theta burst stimulation (iTBS): study protocol for a randomized double-blind sham-controlled trial
Abstract Background Intermittent theta burst stimulation (iTBS) when applied over the left dorsolateral prefrontal cortex (DLPFC) has been shown to be equally effective and safe to treat depression compared to traditional repetitive transcranial magnetic stimulation (rTMS) paradigms. This protocol d...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2023-10-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07674-6 |
| _version_ | 1797451601752883200 |
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| author | Marte Christine Ørbo Ole K. Grønli Camilla Larsen Torgil R. Vangberg Oddgeir Friborg Zsolt Turi Matthias Mittner Gabor Csifcsak Per M. Aslaksen |
| author_facet | Marte Christine Ørbo Ole K. Grønli Camilla Larsen Torgil R. Vangberg Oddgeir Friborg Zsolt Turi Matthias Mittner Gabor Csifcsak Per M. Aslaksen |
| author_sort | Marte Christine Ørbo |
| collection | DOAJ |
| description | Abstract Background Intermittent theta burst stimulation (iTBS) when applied over the left dorsolateral prefrontal cortex (DLPFC) has been shown to be equally effective and safe to treat depression compared to traditional repetitive transcranial magnetic stimulation (rTMS) paradigms. This protocol describes a funded single-centre, double-blind, randomized placebo-controlled, clinical trial to investigate the antidepressive effects of iTBS and factors associated with an antidepressive response. Methods In this trial, outpatients (N = 96, aged 22–65 years) meeting the diagnostic criteria for at least moderate depression (Montgomery and Aasberg Depression Rating Scale score ≥ 20) will be enrolled prospectively and receive ten, once-a-day sessions of either active iTBS or sham iTBS to the left DLPFC, localized via a neuronavigation system. Participants may have any degree of treatment resistance. Prior to stimulation, participants will undergo a thorough safety screening and a brief diagnostic assessment, genetic analysis of brain-derived neurotropic factor, 5-HTTLPR and 5-HT1A, and cerebral MRI assessments. A selection of neuropsychological tests and questionnaires will be administered prior to stimulation and after ten stimulations. An additional follow-up will be conducted 4 weeks after the last stimulation. The first participant was enrolled on June 4, 2022. Study completion will be in December 2027. The project is approved by the Regional Ethical Committee of Medicine and Health Sciences, Northern Norway, project number 228765. The trial will be conducted according to Good Clinical Practice and published safety guidelines on rTMS treatment. Discussion The aims of the present trial are to investigate the antidepressive effect of a 10-session iTBS protocol on moderately depressed outpatients and to explore the factors that can explain the reduction in depressive symptoms after iTBS but also a poorer response to the treatment. In separate, but related work packages, the trial will assess how clinical, cognitive, brain imaging and genetic measures at baseline relate to the variability in the antidepressive effects of iTBS. Trial registration ClinicalTrials.gov NCT05516095. Retrospectively registered on August 25, 2022. |
| first_indexed | 2024-03-09T14:57:00Z |
| format | Article |
| id | doaj.art-4f38f013a0324ddfbce399f76000014e |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-09T14:57:00Z |
| publishDate | 2023-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-4f38f013a0324ddfbce399f76000014e2023-11-26T14:08:54ZengBMCTrials1745-62152023-10-012411910.1186/s13063-023-07674-6The antidepressant effect of intermittent theta burst stimulation (iTBS): study protocol for a randomized double-blind sham-controlled trialMarte Christine Ørbo0Ole K. Grønli1Camilla Larsen2Torgil R. Vangberg3Oddgeir Friborg4Zsolt Turi5Matthias Mittner6Gabor Csifcsak7Per M. Aslaksen8Department of Psychology, Faculty of Health Sciences, UIT the Arctic University of NorwayDepartment of Clinical Medicine, Faculty of Health Sciences, UIT the Arctic University of NorwayDepartment of Psychology, Faculty of Health Sciences, UIT the Arctic University of NorwayDepartment of Clinical Medicine, Faculty of Health Sciences, UIT the Arctic University of NorwayDepartment of Psychology, Faculty of Health Sciences, UIT the Arctic University of NorwayDepartment of Neuroanatomy, Institute for Anatomy and Cell Biology, University of FreiburgDepartment of Psychology, Faculty of Health Sciences, UIT the Arctic University of NorwayDepartment of Psychology, Faculty of Health Sciences, UIT the Arctic University of NorwayDepartment of Psychology, Faculty of Health Sciences, UIT the Arctic University of NorwayAbstract Background Intermittent theta burst stimulation (iTBS) when applied over the left dorsolateral prefrontal cortex (DLPFC) has been shown to be equally effective and safe to treat depression compared to traditional repetitive transcranial magnetic stimulation (rTMS) paradigms. This protocol describes a funded single-centre, double-blind, randomized placebo-controlled, clinical trial to investigate the antidepressive effects of iTBS and factors associated with an antidepressive response. Methods In this trial, outpatients (N = 96, aged 22–65 years) meeting the diagnostic criteria for at least moderate depression (Montgomery and Aasberg Depression Rating Scale score ≥ 20) will be enrolled prospectively and receive ten, once-a-day sessions of either active iTBS or sham iTBS to the left DLPFC, localized via a neuronavigation system. Participants may have any degree of treatment resistance. Prior to stimulation, participants will undergo a thorough safety screening and a brief diagnostic assessment, genetic analysis of brain-derived neurotropic factor, 5-HTTLPR and 5-HT1A, and cerebral MRI assessments. A selection of neuropsychological tests and questionnaires will be administered prior to stimulation and after ten stimulations. An additional follow-up will be conducted 4 weeks after the last stimulation. The first participant was enrolled on June 4, 2022. Study completion will be in December 2027. The project is approved by the Regional Ethical Committee of Medicine and Health Sciences, Northern Norway, project number 228765. The trial will be conducted according to Good Clinical Practice and published safety guidelines on rTMS treatment. Discussion The aims of the present trial are to investigate the antidepressive effect of a 10-session iTBS protocol on moderately depressed outpatients and to explore the factors that can explain the reduction in depressive symptoms after iTBS but also a poorer response to the treatment. In separate, but related work packages, the trial will assess how clinical, cognitive, brain imaging and genetic measures at baseline relate to the variability in the antidepressive effects of iTBS. Trial registration ClinicalTrials.gov NCT05516095. Retrospectively registered on August 25, 2022.https://doi.org/10.1186/s13063-023-07674-6Intermittent theta burst stimulationDepressionCognitionRandomized controlled trialMagnetic resonance imagingGenetic factors |
| spellingShingle | Marte Christine Ørbo Ole K. Grønli Camilla Larsen Torgil R. Vangberg Oddgeir Friborg Zsolt Turi Matthias Mittner Gabor Csifcsak Per M. Aslaksen The antidepressant effect of intermittent theta burst stimulation (iTBS): study protocol for a randomized double-blind sham-controlled trial Trials Intermittent theta burst stimulation Depression Cognition Randomized controlled trial Magnetic resonance imaging Genetic factors |
| title | The antidepressant effect of intermittent theta burst stimulation (iTBS): study protocol for a randomized double-blind sham-controlled trial |
| title_full | The antidepressant effect of intermittent theta burst stimulation (iTBS): study protocol for a randomized double-blind sham-controlled trial |
| title_fullStr | The antidepressant effect of intermittent theta burst stimulation (iTBS): study protocol for a randomized double-blind sham-controlled trial |
| title_full_unstemmed | The antidepressant effect of intermittent theta burst stimulation (iTBS): study protocol for a randomized double-blind sham-controlled trial |
| title_short | The antidepressant effect of intermittent theta burst stimulation (iTBS): study protocol for a randomized double-blind sham-controlled trial |
| title_sort | antidepressant effect of intermittent theta burst stimulation itbs study protocol for a randomized double blind sham controlled trial |
| topic | Intermittent theta burst stimulation Depression Cognition Randomized controlled trial Magnetic resonance imaging Genetic factors |
| url | https://doi.org/10.1186/s13063-023-07674-6 |
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