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Study protocol
Antoni Valero-Cabré
Corresponding Author
ORCiD: https://orcid.org/0000-0002-5033-2279
License:
This work is licensed under a CC BY 4.0 License. Read Full License
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 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 which could reflect stimulation-induced neuroplasticity.
Methods
Double-blind sham-controlled randomized study using tDCS applied daily during 10 days, and language/semantic and imaging assessments at 4 time-points: baseline, 3 days, 2 weeks and 4 months after the 10 stimulation sessions. Language/semantic assessments will be applied at the 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 the two-weeks’ 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 3 subgroups: left-anodal tDCS (n=20), right-cathodal tDCS (n=20) and sham tDCS (n=20). The stimulation duration will be sustained for 20 minutes 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 age, gender and education-matched healthy participants (n=20) will also be recruited and tested to provide normative values for the language/semantic tasks and imaging measures.
Discussion
The study aims at assessing 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.
Keywords
Non-invasive brain stimulation, transcranial direct current stimulation, semantic dementia, primary progressive aphasia, language impairments, neurodegenerative diseases, neurology
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CURRENT STATUS: Published
View the published article at Trials.
Version 1
Posted 01 Jun, 2019
No community comments so far
Editorial decision: Accept
On 23 Jul, 2019
Editor assigned
On 12 Jul, 2019
Submission checks complete
On 30 May, 2019
First submitted
On 21 May, 2019
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Subject Areas
Translational Medicine
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Antoni Valero-Cabré
Corresponding Author
ORCiD: https://orcid.org/0000-0002-5033-2279
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
Version 1
Posted 01 Jun, 2019
No community comments so far
Editorial decision: Accept
On 23 Jul, 2019
Editor assigned
On 12 Jul, 2019
Submission checks complete
On 30 May, 2019
First submitted
On 21 May, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Translational Medicine
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
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 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 which could reflect stimulation-induced neuroplasticity.
Methods
Double-blind sham-controlled randomized study using tDCS applied daily during 10 days, and language/semantic and imaging assessments at 4 time-points: baseline, 3 days, 2 weeks and 4 months after the 10 stimulation sessions. Language/semantic assessments will be applied at the 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 the two-weeks’ 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 3 subgroups: left-anodal tDCS (n=20), right-cathodal tDCS (n=20) and sham tDCS (n=20). The stimulation duration will be sustained for 20 minutes 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 age, gender and education-matched healthy participants (n=20) will also be recruited and tested to provide normative values for the language/semantic tasks and imaging measures.
Discussion
The study aims at assessing 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.
Figure 1
Figure 2
Figure 3
Figure 4
Figure 5
This is a list of supplementary files associated with this preprint. Click to download.
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