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The Effects of a Multimodal Approach for the Treatment of PPA

NCT04187391 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2024-10-03

No results posted yet for this study

Summary

Primary Progressive Aphasia (PPA) is an untreatable neurodegenerative disorder that disrupts language functions. Available therapies are mainly symptomatic and recently attention has been gained by new techniques that allow for noninvasive brain stimulation such as transcranial direct current stimulation (tDCS). The primary objective of this study is to evaluate whether the application of Active tDCS (anode over the left dorsolateral prefrontal cortex- DLPFC with the cathode over the right supraorbital region) to the scalp during individualized language training, would improve naming abilities in the agrammatic variant of PPA (avPPA) more than use of one methodology alone. The effect of treatment on the clinical symptoms will be related to changes in brain activity (Magnetic Resonance Imaging, MRI and Functional near-infrared spectroscopy fNIRS) and in biological markers, using a multimodal approach. Finally, we will assess the long-term effects of this approach.

Conditions

  • Primary Progressive Aphasia

Interventions

DEVICE

Active tDCS

Active tDCS anode is applied over the left DLPFC with the cathode over the right supraorbital region.

DEVICE

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.

BEHAVIORAL

Language training

patients receive language training

BEHAVIORAL

Unstructured cognitive training

patients receive unstructured cognitive training.

Sponsors & Collaborators

  • Asst Degli Spedali Civili Di Brescia

    collaborator OTHER

  • IRCCS Centro San Giovanni di Dio Fatebenefratelli

    lead OTHER

Principal Investigators

  • Rosa Manenti, PhD · IRCCS Istituto Centro San Giovanni di Dio- Fatebenefratelli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2024-03-31
Completion
2024-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04187391 on ClinicalTrials.gov