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.

Details

Title
Testing the therapeutic effects of transcranial direct current stimulation (tDCS) in semantic dementia: a double blind, sham controlled, randomized clinical trial
Author
Sanches, Clara 1 ; Levy, Richard 2 ; Benisty, Sarah 3 ; Volpe-Gillot, Lisette 4 ; Habert, Marie-Odile 5 ; Kas, Aurelie 6 ; Ströer, Sébastian 7 ; Pyatigorskaya, Nadya 8 ; Kaglik, Anna 9 ; Bourbon, Angelina 1 ; Dubois, Bruno 2 ; Migliaccio, Raffaella 2 ; Valero-Cabré, Antoni 10   VIAFID ORCID Logo  ; Teichmann, Marc 2 

1  Institut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Frontlab team, Paris, France (GRID:grid.411439.a) (ISNI:0000 0001 2150 9058); Groupe de Dynamiques Cérébrales, Plasticité et Rééducation, FrontLab team, Institut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Paris, France (GRID:grid.411439.a) (ISNI:0000 0001 2150 9058) 
2  Institut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Frontlab team, Paris, France (GRID:grid.411439.a) (ISNI:0000 0001 2150 9058); Pitié Salpêtrière Hospital, AP-HP, Department of Neurology, National Reference Center for « Rare or Early Onset Dementias », Paris, France (GRID:grid.411439.a) (ISNI:0000 0001 2150 9058) 
3  Fondation Ophtalmologique Rothschild, Paris, France (GRID:grid.417888.a) (ISNI:0000 0001 2177 525X) 
4  Espace IMAGINE, Hôpital Léopold Bellan, Paris, France (GRID:grid.417888.a) 
5  Hôpital de la Pitié-Salpêtrière, AP-HP, Department of Nuclear Medicine, Paris, France (GRID:grid.411439.a) (ISNI:0000 0001 2150 9058); CATI Multicenter Neuroimaging Platform, Paris, France (GRID:grid.411439.a); Laboratoire d’Imagerie Biomédicale, Sorbonne Université, Inserm U1146, CNRS UMR, Paris, France (GRID:grid.4444.0) (ISNI:0000 0001 2112 9282) 
6  Hôpital de la Pitié-Salpêtrière, AP-HP, Department of Nuclear Medicine, Paris, France (GRID:grid.411439.a) (ISNI:0000 0001 2150 9058); Laboratoire d’Imagerie Biomédicale, Sorbonne Université, Inserm U1146, CNRS UMR, Paris, France (GRID:grid.4444.0) (ISNI:0000 0001 2112 9282) 
7  Hôpital de la Pitié-Salpêtrière, AP-HP, Department of Neuroradiology, Paris, France (GRID:grid.411439.a) (ISNI:0000 0001 2150 9058) 
8  Hôpital de la Pitié-Salpêtrière, AP-HP, Department of Neuroradiology, Paris, France (GRID:grid.411439.a) (ISNI:0000 0001 2150 9058); Institut du Cerveau et de la Moelle Epinière, Center for NeuroImaging Research – CENIR, Paris, France (GRID:grid.425274.2) (ISNI:0000 0004 0620 5939) 
9  Institut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Frontlab team, Paris, France (GRID:grid.411439.a) (ISNI:0000 0001 2150 9058); Groupe de Dynamiques Cérébrales, Plasticité et Rééducation, FrontLab team, Institut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Paris, France (GRID:grid.411439.a) (ISNI:0000 0001 2150 9058); Unité de Recherche Clinique (URC) Pitié-Salpêtrière, Charles Foix, AP-HP, Paris, France (GRID:grid.50550.35) (ISNI:0000 0001 2175 4109) 
10  Institut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Frontlab team, Paris, France (GRID:grid.411439.a) (ISNI:0000 0001 2150 9058); Groupe de Dynamiques Cérébrales, Plasticité et Rééducation, FrontLab team, Institut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Paris, France (GRID:grid.411439.a) (ISNI:0000 0001 2150 9058); Boston University School of Medicine, Laboratory for Cerebral Dynamics Plasticity and Rehabilitation, Boston, USA (GRID:grid.475010.7) (ISNI:0000 0004 0367 5222); Open University of Catalonia (UOC), Cognitive Neuroscience and Information Technology Research Program, Barcelona, Spain (GRID:grid.36083.3e) (ISNI:0000 0001 2171 6620) 
Pages
632
Publication year
2019
Publication date
Dec 2019
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-019-3613-z
ProQuest document ID
2795341226
Copyright
© The Author(s). 2019. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.