Treatment of auditory hallucinations with bilateral theta burst stimulation (cTBS): protocol of a randomized, double-blind, placebo-controlled, multicenter trial.
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| Title: | Treatment of auditory hallucinations with bilateral theta burst stimulation (cTBS): protocol of a randomized, double-blind, placebo-controlled, multicenter trial. |
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| Authors: | Plewnia, Christian, Brendel, Bettina, Schwippel, Tobias, Martus, Peter, Cordes, Joachim, Hasan, Alkomiet, Fallgatter, Andreas J. |
| Source: | European Archives of Psychiatry & Clinical Neuroscience. Oct2018, Vol. 268 Issue 7, p663-673. 11p. 1 Diagram, 1 Chart. |
| Subjects: | Auditory hallucinations, Transcranial magnetic stimulation, Brain stimulation, Schizophrenia, Randomized controlled trials, Therapeutics |
| Abstract: | Auditory verbal hallucinations (AH) are core symptoms of schizophrenia. They are often severely distressing and refractory to therapy. Their perception is associated with increased activity in temporoparietal areas of the brain. Repetitive transcranial magnetic stimulation (rTMS) can reduce focal brain hyperactivity and has been shown to ameliorate AH. However, controlled multicenter clinical trials are still missing, effect sizes are moderate, and the treatment with rTMS is time consuming. Continuous theta burst stimulation (cTBS) is a quicker and potentially more effective technique to reduce cortical hyperactivity. First case and pilot studies indicate effectiveness in the treatment of AH. In this randomized, sham-controlled, double-blind multicenter clinical trial, 86 patients with schizophrenia spectrum disorder will be randomized to either cTBS or sham to the left and right temporoparietal cortex during three consecutive weeks (15 sessions totally). In each session, both hemispheres will be stimulated sequentially. The order in the first session (left-right or right-left, respectively) will be determined by randomization and alternated in all following sessions. Primary outcome is the reduction of mean PSYRATS-AH score after cTBS as compared to sham treatment. Follow-up measurements will be performed 1, 3 and 6 months after the end of the treatment. Statistical analysis will be based on the intention-to-treat population including all randomized patients using an analysis of covariance. This multicenter-controlled clinical trial will be able to provide decisive evidence for the efficacy of cTBS in the treatment of AH. The results will be suitable to clarify the role of this innovative, pathophysiology-based therapeutic approach in treatment guidelines for AH.Trial registry: ClinicalTrials.gov identifier: NCT02670291. [ABSTRACT FROM AUTHOR] |
| Copyright of European Archives of Psychiatry & Clinical Neuroscience is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Psychology and Behavioral Sciences Collection |
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| Header | DbId: pbh DbLabel: Psychology and Behavioral Sciences Collection An: 131720436 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Treatment of auditory hallucinations with bilateral theta burst stimulation (cTBS): protocol of a randomized, double-blind, placebo-controlled, multicenter trial. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Plewnia%2C+Christian%22">Plewnia, Christian</searchLink><br /><searchLink fieldCode="AR" term="%22Brendel%2C+Bettina%22">Brendel, Bettina</searchLink><br /><searchLink fieldCode="AR" term="%22Schwippel%2C+Tobias%22">Schwippel, Tobias</searchLink><br /><searchLink fieldCode="AR" term="%22Martus%2C+Peter%22">Martus, Peter</searchLink><br /><searchLink fieldCode="AR" term="%22Cordes%2C+Joachim%22">Cordes, Joachim</searchLink><br /><searchLink fieldCode="AR" term="%22Hasan%2C+Alkomiet%22">Hasan, Alkomiet</searchLink><br /><searchLink fieldCode="AR" term="%22Fallgatter%2C+Andreas+J%2E%22">Fallgatter, Andreas J.</searchLink> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22European+Archives+of+Psychiatry+%26+Clinical+Neuroscience%22">European Archives of Psychiatry & Clinical Neuroscience</searchLink>. Oct2018, Vol. 268 Issue 7, p663-673. 11p. 1 Diagram, 1 Chart. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22Auditory+hallucinations%22">Auditory hallucinations</searchLink><br /><searchLink fieldCode="DE" term="%22Transcranial+magnetic+stimulation%22">Transcranial magnetic stimulation</searchLink><br /><searchLink fieldCode="DE" term="%22Brain+stimulation%22">Brain stimulation</searchLink><br /><searchLink fieldCode="DE" term="%22Schizophrenia%22">Schizophrenia</searchLink><br /><searchLink fieldCode="DE" term="%22Randomized+controlled+trials%22">Randomized controlled trials</searchLink><br /><searchLink fieldCode="DE" term="%22Therapeutics%22">Therapeutics</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Auditory verbal hallucinations (AH) are core symptoms of schizophrenia. They are often severely distressing and refractory to therapy. Their perception is associated with increased activity in temporoparietal areas of the brain. Repetitive transcranial magnetic stimulation (rTMS) can reduce focal brain hyperactivity and has been shown to ameliorate AH. However, controlled multicenter clinical trials are still missing, effect sizes are moderate, and the treatment with rTMS is time consuming. Continuous theta burst stimulation (cTBS) is a quicker and potentially more effective technique to reduce cortical hyperactivity. First case and pilot studies indicate effectiveness in the treatment of AH. In this randomized, sham-controlled, double-blind multicenter clinical trial, 86 patients with schizophrenia spectrum disorder will be randomized to either cTBS or sham to the left and right temporoparietal cortex during three consecutive weeks (15 sessions totally). In each session, both hemispheres will be stimulated sequentially. The order in the first session (left-right or right-left, respectively) will be determined by randomization and alternated in all following sessions. Primary outcome is the reduction of mean PSYRATS-AH score after cTBS as compared to sham treatment. Follow-up measurements will be performed 1, 3 and 6 months after the end of the treatment. Statistical analysis will be based on the intention-to-treat population including all randomized patients using an analysis of covariance. This multicenter-controlled clinical trial will be able to provide decisive evidence for the efficacy of cTBS in the treatment of AH. The results will be suitable to clarify the role of this innovative, pathophysiology-based therapeutic approach in treatment guidelines for AH.Trial registry: ClinicalTrials.gov identifier: NCT02670291. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of European Archives of Psychiatry & Clinical Neuroscience is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1007/s00406-017-0861-3 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 11 StartPage: 663 Subjects: – SubjectFull: Auditory hallucinations Type: general – SubjectFull: Transcranial magnetic stimulation Type: general – SubjectFull: Brain stimulation Type: general – SubjectFull: Schizophrenia Type: general – SubjectFull: Randomized controlled trials Type: general – SubjectFull: Therapeutics Type: general Titles: – TitleFull: Treatment of auditory hallucinations with bilateral theta burst stimulation (cTBS): protocol of a randomized, double-blind, placebo-controlled, multicenter trial. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Plewnia, Christian – PersonEntity: Name: NameFull: Brendel, Bettina – PersonEntity: Name: NameFull: Schwippel, Tobias – PersonEntity: Name: NameFull: Martus, Peter – PersonEntity: Name: NameFull: Cordes, Joachim – PersonEntity: Name: NameFull: Hasan, Alkomiet – PersonEntity: Name: NameFull: Fallgatter, Andreas J. IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 10 Text: Oct2018 Type: published Y: 2018 Identifiers: – Type: issn-print Value: 09401334 Numbering: – Type: volume Value: 268 – Type: issue Value: 7 Titles: – TitleFull: European Archives of Psychiatry & Clinical Neuroscience Type: main |
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