A naturalistic study comparing the efficacy of unilateral and bilateral sequential theta burst stimulation in treating major depression – the U-B-D study protocol
Abstract Background Major depressive disorder (MDD) is a prevalent mental health condition affecting millions worldwide, leading to disability and reduced quality of life. MDD poses a global health priority due to its early onset and association with other disabling conditions. Available treatments...
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| Format: | Article |
| Language: | English |
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BMC
2023-10-01
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| Series: | BMC Psychiatry |
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| Online Access: | https://doi.org/10.1186/s12888-023-05243-4 |
| _version_ | 1797557414828965888 |
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| author | Molly Watson Arthur R. Chaves Abir Gebara Manon Desforges Antoinette Broomfield Noémie Landry Alexandra Lemoyne Stacey Shim Jessica Drodge Jennifer Cuda Nasim Kiaee Youssef Nasr Christophe Carleton Zafiris J. Daskalakis Reggie Taylor Lauri Tuominen Ram Brender Ruxandra Antochi Lisa McMurray Sara Tremblay |
| author_facet | Molly Watson Arthur R. Chaves Abir Gebara Manon Desforges Antoinette Broomfield Noémie Landry Alexandra Lemoyne Stacey Shim Jessica Drodge Jennifer Cuda Nasim Kiaee Youssef Nasr Christophe Carleton Zafiris J. Daskalakis Reggie Taylor Lauri Tuominen Ram Brender Ruxandra Antochi Lisa McMurray Sara Tremblay |
| author_sort | Molly Watson |
| collection | DOAJ |
| description | Abstract Background Major depressive disorder (MDD) is a prevalent mental health condition affecting millions worldwide, leading to disability and reduced quality of life. MDD poses a global health priority due to its early onset and association with other disabling conditions. Available treatments for MDD exhibit varying effectiveness, and a substantial portion of individuals remain resistant to treatment. Repetitive transcranial magnetic stimulation (rTMS), applied to the left and/or right dorsolateral prefrontal cortex (DLPFC), is an alternative treatment strategy for those experiencing treatment-resistant MDD. The objective of this study is to investigate whether this newer form of rTMS, namely theta burst stimulation (TBS), when performed unilaterally or bilaterally, is efficacious in treatment-resistant MDD. Methods In this naturalistic, randomized double-blinded non-inferiority trial, participants with a major depressive episode will be randomized to receive either unilateral (i.e., continuous TBS [cTBS] to the right and sham TBS to the left DLPFC) or bilateral sequential TBS (i.e., cTBS to the right and intermittent TBS [iTBS] to the left DLPFC) delivered 5 days a week for 4–6 weeks. Responders will move onto a 6-month flexible maintenance phase where TBS treatment will be delivered at a decreasing frequency depending on degree of symptom mitigation. Several clinical assessments and neuroimaging and neurophysiological biomarkers will be collected to investigate treatment response and potential associated biomarkers. A non-inferiority analysis will investigate whether bilateral sequential TBS is non-inferior to unilateral TBS and regression analyses will investigate biomarkers of treatment response. We expect to recruit a maximal of 256 participants. This trial is approved by the Research Ethics Board of The Royal's Institute of Mental Health Research (REB# 2,019,071) and will follow the Declaration of Helsinki. Findings will be published in peer-reviewed journals. Discussion Comprehensive assessment of symptoms and neurophysiological biomarkers will contribute to understanding the differential efficacy of the tested treatment protocols, identifying biomarkers for treatment response, and shedding light into underlying mechanisms of TBS. Our findings will inform future clinical trials and aid in personalizing treatment selection and scheduling for individuals with MDD. Trial registration The trial is registered on https://clinicaltrials.gov/ct2/home (#NCT04142996). |
| first_indexed | 2024-03-10T17:16:45Z |
| format | Article |
| id | doaj.art-ec8eaf470d53460cbbc073feccafc57f |
| institution | Directory Open Access Journal |
| issn | 1471-244X |
| language | English |
| last_indexed | 2024-03-10T17:16:45Z |
| publishDate | 2023-10-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Psychiatry |
| spelling | doaj.art-ec8eaf470d53460cbbc073feccafc57f2023-11-20T10:29:53ZengBMCBMC Psychiatry1471-244X2023-10-0123112310.1186/s12888-023-05243-4A naturalistic study comparing the efficacy of unilateral and bilateral sequential theta burst stimulation in treating major depression – the U-B-D study protocolMolly Watson0Arthur R. Chaves1Abir Gebara2Manon Desforges3Antoinette Broomfield4Noémie Landry5Alexandra Lemoyne6Stacey Shim7Jessica Drodge8Jennifer Cuda9Nasim Kiaee10Youssef Nasr11Christophe Carleton12Zafiris J. Daskalakis13Reggie Taylor14Lauri Tuominen15Ram Brender16Ruxandra Antochi17Lisa McMurray18Sara Tremblay19University of Ottawa Institute of Mental Health Research at The RoyalUniversity of Ottawa Institute of Mental Health Research at The RoyalSchool of Medicine, Stanford UniversityUniversity of Ottawa Institute of Mental Health Research at The RoyalUniversity of Ottawa Institute of Mental Health Research at The RoyalUniversity of Ottawa Institute of Mental Health Research at The RoyalUniversity of Ottawa Institute of Mental Health Research at The RoyalUniversity of Ottawa Institute of Mental Health Research at The RoyalUniversity of Ottawa Institute of Mental Health Research at The RoyalUniversity of Ottawa Institute of Mental Health Research at The RoyalUniversity of Ottawa Institute of Mental Health Research at The RoyalUniversity of Ottawa Institute of Mental Health Research at The RoyalUniversity of Ottawa Institute of Mental Health Research at The RoyalDepartment of Psychiatry, University California San DiegoUniversity of Ottawa Institute of Mental Health Research at The RoyalUniversity of Ottawa Institute of Mental Health Research at The RoyalDepartment of Psychiatry, University of OttawaDepartment of Psychiatry, University of OttawaDepartment of Psychiatry, University of OttawaUniversity of Ottawa Institute of Mental Health Research at The RoyalAbstract Background Major depressive disorder (MDD) is a prevalent mental health condition affecting millions worldwide, leading to disability and reduced quality of life. MDD poses a global health priority due to its early onset and association with other disabling conditions. Available treatments for MDD exhibit varying effectiveness, and a substantial portion of individuals remain resistant to treatment. Repetitive transcranial magnetic stimulation (rTMS), applied to the left and/or right dorsolateral prefrontal cortex (DLPFC), is an alternative treatment strategy for those experiencing treatment-resistant MDD. The objective of this study is to investigate whether this newer form of rTMS, namely theta burst stimulation (TBS), when performed unilaterally or bilaterally, is efficacious in treatment-resistant MDD. Methods In this naturalistic, randomized double-blinded non-inferiority trial, participants with a major depressive episode will be randomized to receive either unilateral (i.e., continuous TBS [cTBS] to the right and sham TBS to the left DLPFC) or bilateral sequential TBS (i.e., cTBS to the right and intermittent TBS [iTBS] to the left DLPFC) delivered 5 days a week for 4–6 weeks. Responders will move onto a 6-month flexible maintenance phase where TBS treatment will be delivered at a decreasing frequency depending on degree of symptom mitigation. Several clinical assessments and neuroimaging and neurophysiological biomarkers will be collected to investigate treatment response and potential associated biomarkers. A non-inferiority analysis will investigate whether bilateral sequential TBS is non-inferior to unilateral TBS and regression analyses will investigate biomarkers of treatment response. We expect to recruit a maximal of 256 participants. This trial is approved by the Research Ethics Board of The Royal's Institute of Mental Health Research (REB# 2,019,071) and will follow the Declaration of Helsinki. Findings will be published in peer-reviewed journals. Discussion Comprehensive assessment of symptoms and neurophysiological biomarkers will contribute to understanding the differential efficacy of the tested treatment protocols, identifying biomarkers for treatment response, and shedding light into underlying mechanisms of TBS. Our findings will inform future clinical trials and aid in personalizing treatment selection and scheduling for individuals with MDD. Trial registration The trial is registered on https://clinicaltrials.gov/ct2/home (#NCT04142996).https://doi.org/10.1186/s12888-023-05243-4Major depressive disorderTranscranial magnetic stimulation (TMS)Theta burst stimulation (TBS)Magnetic resonance spectroscopyEvoked potentialTMS-EEG |
| spellingShingle | Molly Watson Arthur R. Chaves Abir Gebara Manon Desforges Antoinette Broomfield Noémie Landry Alexandra Lemoyne Stacey Shim Jessica Drodge Jennifer Cuda Nasim Kiaee Youssef Nasr Christophe Carleton Zafiris J. Daskalakis Reggie Taylor Lauri Tuominen Ram Brender Ruxandra Antochi Lisa McMurray Sara Tremblay A naturalistic study comparing the efficacy of unilateral and bilateral sequential theta burst stimulation in treating major depression – the U-B-D study protocol BMC Psychiatry Major depressive disorder Transcranial magnetic stimulation (TMS) Theta burst stimulation (TBS) Magnetic resonance spectroscopy Evoked potential TMS-EEG |
| title | A naturalistic study comparing the efficacy of unilateral and bilateral sequential theta burst stimulation in treating major depression – the U-B-D study protocol |
| title_full | A naturalistic study comparing the efficacy of unilateral and bilateral sequential theta burst stimulation in treating major depression – the U-B-D study protocol |
| title_fullStr | A naturalistic study comparing the efficacy of unilateral and bilateral sequential theta burst stimulation in treating major depression – the U-B-D study protocol |
| title_full_unstemmed | A naturalistic study comparing the efficacy of unilateral and bilateral sequential theta burst stimulation in treating major depression – the U-B-D study protocol |
| title_short | A naturalistic study comparing the efficacy of unilateral and bilateral sequential theta burst stimulation in treating major depression – the U-B-D study protocol |
| title_sort | naturalistic study comparing the efficacy of unilateral and bilateral sequential theta burst stimulation in treating major depression the u b d study protocol |
| topic | Major depressive disorder Transcranial magnetic stimulation (TMS) Theta burst stimulation (TBS) Magnetic resonance spectroscopy Evoked potential TMS-EEG |
| url | https://doi.org/10.1186/s12888-023-05243-4 |
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