Testing the therapeutic effects of transcranial direct current stimulation (tDCS) in semantic dementia: a double blind, sham controlled, randomized clinical trial
Abstract Background Semantic dementia is a neurodegenerative disease that primarily affects the left anterior temporal lobe, resulting in a gradual loss of conceptual knowledge. There is currently no validated treatment. Transcranial stimulation has provided evidence for long-lasting language effect...
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2019-11-01
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Online Access: | http://link.springer.com/article/10.1186/s13063-019-3613-z |
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doaj-106bc62b3e4f47db83990853ee891258 |
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record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Clara Sanches Richard Levy Sarah Benisty Lisette Volpe-Gillot Marie-Odile Habert Aurelie Kas Sébastian Ströer Nadya Pyatigorskaya Anna Kaglik Angelina Bourbon Bruno Dubois Raffaella Migliaccio Antoni Valero-Cabré Marc Teichmann |
spellingShingle |
Clara Sanches Richard Levy Sarah Benisty Lisette Volpe-Gillot Marie-Odile Habert Aurelie Kas Sébastian Ströer Nadya Pyatigorskaya Anna Kaglik Angelina Bourbon Bruno Dubois Raffaella Migliaccio Antoni Valero-Cabré Marc Teichmann Testing the therapeutic effects of transcranial direct current stimulation (tDCS) in semantic dementia: a double blind, sham controlled, randomized clinical trial Trials Non-invasive brain stimulation Transcranial direct current stimulation Semantic dementia Primary progressive aphasia Language impairments Neurodegenerative diseases |
author_facet |
Clara Sanches Richard Levy Sarah Benisty Lisette Volpe-Gillot Marie-Odile Habert Aurelie Kas Sébastian Ströer Nadya Pyatigorskaya Anna Kaglik Angelina Bourbon Bruno Dubois Raffaella Migliaccio Antoni Valero-Cabré Marc Teichmann |
author_sort |
Clara Sanches |
title |
Testing the therapeutic effects of transcranial direct current stimulation (tDCS) in semantic dementia: a double blind, sham controlled, randomized clinical trial |
title_short |
Testing the therapeutic effects of transcranial direct current stimulation (tDCS) in semantic dementia: a double blind, sham controlled, randomized clinical trial |
title_full |
Testing the therapeutic effects of transcranial direct current stimulation (tDCS) in semantic dementia: a double blind, sham controlled, randomized clinical trial |
title_fullStr |
Testing the therapeutic effects of transcranial direct current stimulation (tDCS) in semantic dementia: a double blind, sham controlled, randomized clinical trial |
title_full_unstemmed |
Testing the therapeutic effects of transcranial direct current stimulation (tDCS) in semantic dementia: a double blind, sham controlled, randomized clinical trial |
title_sort |
testing the therapeutic effects of transcranial direct current stimulation (tdcs) in semantic dementia: a double blind, sham controlled, randomized clinical trial |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2019-11-01 |
description |
Abstract Background Semantic dementia is a neurodegenerative disease that primarily affects the left anterior temporal lobe, resulting in a gradual loss of conceptual knowledge. There is currently no validated treatment. Transcranial stimulation has provided evidence for long-lasting language effects presumably linked to stimulation-induced neuroplasticity in post-stroke aphasia. However, studies evaluating its effects in neurodegenerative diseases such as semantic dementia are still rare and evidence from double-blind, prospective, therapeutic trials is required. Objective The primary objective of the present clinical trial (STIM-SD) is to evaluate the therapeutic efficacy of a multiday transcranial direct current stimulation (tDCS) regime on language impairment in patients with semantic dementia. The study also explores the time course of potential tDCS-driven improvements and uses imaging biomarkers that could reflect stimulation-induced neuroplasticity. Methods This is a double-blind, sham-controlled, randomized study using transcranial Direct Current Stimulation (tDCS) applied daily for 10 days, and language/semantic and imaging assessments at four time points: baseline, 3 days, 2 weeks and 4 months after 10 stimulation sessions. Language/semantic assessments will be carried out at these same 4 time points. Fluorodeoxyglucose positron emission tomography (FDG-PET), resting-state functional magnetic resonance imaging (rs-fMRI), T1-weighted images and white matter diffusion tensor imaging (DTI) will be applied at baseline and at the 2-week time point. According to the principle of inter-hemispheric inhibition between left (language-related) and right homotopic regions we will use two stimulation modalities - left-anodal and right-cathodal tDCS over the anterior temporal lobes. Accordingly, the patient population (n = 60) will be subdivided into three subgroups: left-anodal tDCS (n = 20), right-cathodal tDCS (n = 20) and sham tDCS (n = 20). The stimulation will be sustained for 20 min at an intensity of 1.59 mA. It will be delivered through 25cm2-round stimulation electrodes (current density of 0.06 mA/cm2) placed over the left and right anterior temporal lobes for anodal and cathodal stimulation, respectively. A group of healthy participants (n = 20) matched by age, gender and education will also be recruited and tested to provide normative values for the language/semantic tasks and imaging measures. Discussion The aim of this study is to assess the efficacy of tDCS for language/semantic disorders in semantic dementia. A potential treatment would be easily applicable, inexpensive, and renewable when therapeutic effects disappear due to disease progression. Trial registration ClinicalTrials.gov NCT03481933. Registered on March 2018. |
topic |
Non-invasive brain stimulation Transcranial direct current stimulation Semantic dementia Primary progressive aphasia Language impairments Neurodegenerative diseases |
url |
http://link.springer.com/article/10.1186/s13063-019-3613-z |
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doaj-106bc62b3e4f47db83990853ee8912582020-11-25T04:02:51ZengBMCTrials1745-62152019-11-0120111510.1186/s13063-019-3613-zTesting the therapeutic effects of transcranial direct current stimulation (tDCS) in semantic dementia: a double blind, sham controlled, randomized clinical trialClara Sanches0Richard Levy1Sarah Benisty2Lisette Volpe-Gillot3Marie-Odile Habert4Aurelie Kas5Sébastian Ströer6Nadya Pyatigorskaya7Anna Kaglik8Angelina Bourbon9Bruno Dubois10Raffaella Migliaccio11Antoni Valero-Cabré12Marc Teichmann13Institut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Frontlab teamInstitut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Frontlab teamFondation Ophtalmologique RothschildEspace IMAGINE, Hôpital Léopold BellanDepartment of Nuclear Medicine, Hôpital de la Pitié-Salpêtrière, AP-HPDepartment of Nuclear Medicine, Hôpital de la Pitié-Salpêtrière, AP-HPDepartment of Neuroradiology, Hôpital de la Pitié-Salpêtrière, AP-HPDepartment of Neuroradiology, Hôpital de la Pitié-Salpêtrière, AP-HPInstitut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Frontlab teamInstitut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Frontlab teamInstitut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Frontlab teamInstitut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Frontlab teamInstitut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Frontlab teamInstitut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Frontlab teamAbstract Background Semantic dementia is a neurodegenerative disease that primarily affects the left anterior temporal lobe, resulting in a gradual loss of conceptual knowledge. There is currently no validated treatment. Transcranial stimulation has provided evidence for long-lasting language effects presumably linked to stimulation-induced neuroplasticity in post-stroke aphasia. However, studies evaluating its effects in neurodegenerative diseases such as semantic dementia are still rare and evidence from double-blind, prospective, therapeutic trials is required. Objective The primary objective of the present clinical trial (STIM-SD) is to evaluate the therapeutic efficacy of a multiday transcranial direct current stimulation (tDCS) regime on language impairment in patients with semantic dementia. The study also explores the time course of potential tDCS-driven improvements and uses imaging biomarkers that could reflect stimulation-induced neuroplasticity. Methods This is a double-blind, sham-controlled, randomized study using transcranial Direct Current Stimulation (tDCS) applied daily for 10 days, and language/semantic and imaging assessments at four time points: baseline, 3 days, 2 weeks and 4 months after 10 stimulation sessions. Language/semantic assessments will be carried out at these same 4 time points. Fluorodeoxyglucose positron emission tomography (FDG-PET), resting-state functional magnetic resonance imaging (rs-fMRI), T1-weighted images and white matter diffusion tensor imaging (DTI) will be applied at baseline and at the 2-week time point. According to the principle of inter-hemispheric inhibition between left (language-related) and right homotopic regions we will use two stimulation modalities - left-anodal and right-cathodal tDCS over the anterior temporal lobes. Accordingly, the patient population (n = 60) will be subdivided into three subgroups: left-anodal tDCS (n = 20), right-cathodal tDCS (n = 20) and sham tDCS (n = 20). The stimulation will be sustained for 20 min at an intensity of 1.59 mA. It will be delivered through 25cm2-round stimulation electrodes (current density of 0.06 mA/cm2) placed over the left and right anterior temporal lobes for anodal and cathodal stimulation, respectively. A group of healthy participants (n = 20) matched by age, gender and education will also be recruited and tested to provide normative values for the language/semantic tasks and imaging measures. Discussion The aim of this study is to assess the efficacy of tDCS for language/semantic disorders in semantic dementia. A potential treatment would be easily applicable, inexpensive, and renewable when therapeutic effects disappear due to disease progression. Trial registration ClinicalTrials.gov NCT03481933. Registered on March 2018.http://link.springer.com/article/10.1186/s13063-019-3613-zNon-invasive brain stimulationTranscranial direct current stimulationSemantic dementiaPrimary progressive aphasiaLanguage impairmentsNeurodegenerative diseases |