The Effects of a Multimodal Approach for the Treatment of PPA
NCT ID: NCT04187391
Last Updated: 2024-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
47 participants
INTERVENTIONAL
2020-01-15
2024-03-31
Brief Summary
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Detailed Description
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Inclusion criteria will be a diagnosis avPPA according to the current clinical criteria (Gorno-Tempini et al., 2011) and a FTD Clinical Dementia Rating score \>0.5 and \<2. Exclusion criteria will be the presence of any medical or psychiatric illness that could interfere in completing assessments and the presence of any medical condition that represents a contraindication to tDCS. All the patients will undergo five consecutive days a week for two weeks of treatment sessions:
15 patients will receive Active tDCS over DLPFC while performing a language training; 15 patients will receive placebo tDCS during language training; 15 patients will receive Active tDCS over DLPFC during unstructured cognitive training.
Two trained neuropsychologists will administer the neuropsychological testing in two sessions. At baseline (T0), post-treatment (T1) and 3-months (T2) follow-up assessments were conducted by the same assessor. Blood sample withdrawal at baseline (T0) and after the DLPFC-tDCS intervention (T1) will be assessed.
To elucidate the mechanisms underlying tDCS effects, structural imaging, functional connectivity (fMRI) alterations and concentration changes of hemoglobin (fNIRS) will be collected off-line. Each avPPA patient will undergo an MRI scan at the ASST Spedali Civili Brescia, Italy at T0 and T1 and a fNIRS acquisition at the IRCCS Istituto Centro San Giovanni di Dio Brescia, Italy at T0, T1 and T2.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active tDCS plus individual language training
Active tDCS plus individual language training
Active tDCS
Active tDCS anode is applied over the left DLPFC with the cathode over the right supraorbital region.
Language training
patients receive language training
placebo tDCS plus individual language training
placebo tDCS plus individual language training
Placebo tDCS
Placebo tDCS is applied but the current is turned off 10 seconds after the beginning and turned on for the last 10 seconds of the stimulation period.
Language training
patients receive language training
Active tDCS plus unstructured cognitive stimulation
Active tDCS plus unstructured cognitive stimulation
Active tDCS
Active tDCS anode is applied over the left DLPFC with the cathode over the right supraorbital region.
Unstructured cognitive training
patients receive unstructured cognitive training.
Interventions
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Active tDCS
Active tDCS anode is applied over the left DLPFC with the cathode over the right supraorbital region.
Placebo tDCS
Placebo tDCS is applied but the current is turned off 10 seconds after the beginning and turned on for the last 10 seconds of the stimulation period.
Language training
patients receive language training
Unstructured cognitive training
patients receive unstructured cognitive training.
Eligibility Criteria
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Inclusion Criteria
* FTD Clinical Dementia Rating (FTD-CDR) score \>0.5 and \<2
Exclusion Criteria
* Presence of any medical condition that represents a contraindication to tDCS.
40 Years
95 Years
ALL
No
Sponsors
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Asst Degli Spedali Civili Di Brescia
OTHER
IRCCS Centro San Giovanni di Dio Fatebenefratelli
OTHER
Responsible Party
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Principal Investigators
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Rosa Manenti, PhD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Istituto Centro San Giovanni di Dio- Fatebenefratelli
Locations
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IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
Brescia, BS, Italy
Countries
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Other Identifiers
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GR 2018 12365105
Identifier Type: -
Identifier Source: org_study_id
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