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...
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ftdoajarticles:oai:doaj.org/article:4f38f013a0324ddfbce399f76000014e 2023-11-12T04:23:18+01:00 The antidepressant effect of intermittent theta burst stimulation (iTBS): study protocol for a randomized double-blind sham-controlled trial Marte Christine Ørbo Ole K. Grønli Camilla Larsen Torgil R. Vangberg Oddgeir Friborg Zsolt Turi Matthias Mittner Gabor Csifcsak Per M. Aslaksen 2023-10-01T00:00:00Z https://doi.org/10.1186/s13063-023-07674-6 https://doaj.org/article/4f38f013a0324ddfbce399f76000014e EN eng BMC https://doi.org/10.1186/s13063-023-07674-6 https://doaj.org/toc/1745-6215 doi:10.1186/s13063-023-07674-6 1745-6215 https://doaj.org/article/4f38f013a0324ddfbce399f76000014e Trials, Vol 24, Iss 1, Pp 1-9 (2023) Intermittent theta burst stimulation Depression Cognition Randomized controlled trial Magnetic resonance imaging Genetic factors Medicine (General) R5-920 article 2023 ftdoajarticles https://doi.org/10.1186/s13063-023-07674-6 2023-10-15T00:39:38Z 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, ... Article in Journal/Newspaper Northern Norway Directory of Open Access Journals: DOAJ Articles Norway Trials 24 1 |
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Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
language |
English |
topic |
Intermittent theta burst stimulation Depression Cognition Randomized controlled trial Magnetic resonance imaging Genetic factors Medicine (General) R5-920 |
spellingShingle |
Intermittent theta burst stimulation Depression Cognition Randomized controlled trial Magnetic resonance imaging Genetic factors Medicine (General) R5-920 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 |
topic_facet |
Intermittent theta burst stimulation Depression Cognition Randomized controlled trial Magnetic resonance imaging Genetic factors Medicine (General) R5-920 |
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, ... |
format |
Article in Journal/Newspaper |
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 |
title |
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_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_sort |
antidepressant effect of intermittent theta burst stimulation (itbs): study protocol for a randomized double-blind sham-controlled trial |
publisher |
BMC |
publishDate |
2023 |
url |
https://doi.org/10.1186/s13063-023-07674-6 https://doaj.org/article/4f38f013a0324ddfbce399f76000014e |
geographic |
Norway |
geographic_facet |
Norway |
genre |
Northern Norway |
genre_facet |
Northern Norway |
op_source |
Trials, Vol 24, Iss 1, Pp 1-9 (2023) |
op_relation |
https://doi.org/10.1186/s13063-023-07674-6 https://doaj.org/toc/1745-6215 doi:10.1186/s13063-023-07674-6 1745-6215 https://doaj.org/article/4f38f013a0324ddfbce399f76000014e |
op_doi |
https://doi.org/10.1186/s13063-023-07674-6 |
container_title |
Trials |
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24 |
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1 |
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1782338129947000832 |