Evidence map›Paper›PMID 31747967›Full record

Trial reportTrials2019

Testing the therapeutic effects of transcranial direct current stimulation (tDCS) in semantic dementia: a double blind, sham controlled, randomized clinical trial.

Clara Sanches, Richard Levy, Sarah Benisty, Lisette Volpe-Gillot, Marie-Odile Habert, Aurelie Kas, Sébastian Ströer, Nadya Pyatigorskaya, Anna Kaglik, Angelina Bourbon and 4 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03481933 (Investigation of the Therapeutic Value of Transcranial Stimulation With Direct Current on Language Disorders in Semantic Dementia), which is not on this map. Cited by 10 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 3 pooled it
0.9field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03481933 naunknown statusnot on this map

Investigation of the Therapeutic Value of Transcranial Stimulation With Direct Current on Language Disorders in Semantic Dementia

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2018 to 2024Enrolled80ConditionsSemantic DementiaArmsTranscranial stimulation
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 3 syntheses or guidelines pooled it, 14 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 5 institutions in 3 countries.

Clara SanchesInstitut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Frontlab team, Paris, France.
Richard LevyInstitut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Frontlab team, Paris, France.
Sarah BenistyFondation Ophtalmologique Rothschild, Paris, France.
Lisette Volpe-GillotEspace IMAGINE, Hôpital Léopold Bellan, Paris, France.
Marie-Odile HabertDepartment of Nuclear Medicine, Hôpital de la Pitié-Salpêtrière, AP-HP, Paris, France.
Aurelie KasDepartment of Nuclear Medicine, Hôpital de la Pitié-Salpêtrière, AP-HP, Paris, France.
Sébastian StröerDepartment of Neuroradiology, Hôpital de la Pitié-Salpêtrière, AP-HP, Paris, France.
Nadya PyatigorskayaDepartment of Neuroradiology, Hôpital de la Pitié-Salpêtrière, AP-HP, Paris, France.
Anna KaglikInstitut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Frontlab team, Paris, France.
Angelina BourbonInstitut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Frontlab team, Paris, France.
Bruno DuboisInstitut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Frontlab team, Paris, France.
Raffaella MigliaccioInstitut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Frontlab team, Paris, France.
Antoni Valero-CabréInstitut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Frontlab team, Paris, France. antoni.valerocabre@icm-institute.org.ORCID http://orcid.org/0000-0002-5033-2279
Marc TeichmannInstitut du Cerveau et de la Moelle Epinière, ICM, INSERM U 1127, CNRS UMR 7225, Sorbonne Université, Frontlab team, Paris, France. marc.teichmann@psl.aphp.fr.
Centre National de la Recherche Scientifique · FRSorbonne Université · FRBoston University · USFondation Ophtalmologique Adolphe de Rothschild · FRInstitut des Maladies Génétiques Imagine · FR

Funding

Assistance Publique - Hôpitaux de Paris AOR16082
6 · The paper itself

Abstract

backgroundSemantic 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.

objectiveThe 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.

methodsThis 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 25cm 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 registrationClinicalTrials.gov NCT03481933. Registered on March 2018.

Indexed as

Double-Blind MethodElectroencephalographyExecutive FunctionFrontotemporal DementiaHumansMagnetic Resonance ImagingPositron-Emission TomographyResearch DesignSemanticsTranscranial Direct Current StimulationLanguage impairmentsNeurodegenerative diseasesNeurologyNon-invasive brain stimulationPrimary progressive aphasiaSemantic dementiaTranscranial direct current stimulation

Identifiers

PMID31747967
PMCPMC6868701
OpenAlexW2990048624

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.