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NCT Number: NCT04187391

The Effects of a Multimodal Approach for the Treatment of PPA

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.

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Key information

Conditions

Primary Progressive Aphasia Aphasia Aphasia, Primary Progressive Brain Diseases Central Nervous System Diseases Communication Disorders Dementia Language Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders

Age range

40 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli

Brescia, BS, 25125, Italy

About this study

45 patients with avPPA, will be recruited from IRCCS Istituto Centro San Giovanni di Dio Brescia, Italy and ASST Spedali Civili Brescia, Italy .

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis avPPA according to the current clinical criteria (Gorno-Tempini et al., 2011)
  • FTD Clinical Dementia Rating (FTD-CDR) score >0.5 and <2

Exclusion criteria

  • Presence of any medical or psychiatric illness that could interfere in completing assessments
  • Presence of any medical condition that represents a contraindication to tDCS.

Treatment and study plan

active tDCS

Device

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

Placebo tDCS

Device

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

Behavioral

patients receive language training

Unstructured cognitive training

Behavioral

patients receive unstructured cognitive training.

Primary outcomes

  1. Change in naming test scores on Picture Naming Task

    Time frame: Baseline up to 2 weeks and 3 months

    Picture Naming Task: percentage of correct responses (0-100)

Secondary outcomes

  1. Change in quality of life on Stroke and Aphasia Quality of Life

    Time frame: Baseline up to 2 weeks and 3 months

    Stroke and Aphasia Quality of Life (0-5; higher scores=better quality of life)

  2. Change in dementia severity on Frontotemporal Dementia-modified Clinical Dementia Rating Scale

    Time frame: Baseline up to 2 weeks and 3 months

    Frontotemporal Dementia-modified Clinical Dementia Rating Scale (0-3; higher scores=greater dementia severity)

  3. Change in cognitive impairment on Mini Mental State Examination

    Time frame: Baseline up to 2 weeks and 3 months

    Mini Mental State Examination (0-30; higher scores=better cognitive abilities)

  4. Change in verbal long term memory on Story Recall

    Time frame: Baseline up to 2 weeks and 3 months

    Story Recall (0-28; higher scores=better memory abilities)

  5. Change in nonverbal long term memory on Rey-Osterrieth Complex Figure-Recall

    Time frame: Baseline up to 2 weeks and 3 months

    Rey-Osterrieth Complex Figure-Recall (0-36; higher scores=better abilities)

  6. Change in attentional abilities on Trial Making Test

    Time frame: Baseline up to 2 weeks and 3 months

    Trial Making Test (milliseconds; higher scores=worse abilities)

  7. Change in constructional praxia on Rey-Osterrieth Complex Figure-Copy

    Time frame: Baseline up to 2 weeks and 3 months

    Rey-Osterrieth Complex Figure-Copy (0-36; higher scores=better abilities)

  8. Change in fluency abilities on Verbal Fluency (semantic and phonemic)

    Time frame: Baseline up to 2 weeks and 3 months

    Verbal Fluency (semantic and phonemic) Test (higher scores=better abilities)

  9. Change in aphasia severity on Screening for Neurodegenerative Aphasia

    Time frame: Baseline up to 2 weeks and 3 months

    Screening for Neurodegenerative Aphasia Battery (higher scores=better abilities)

  10. Change in naming on naming subtest from Aachener Aphasie Test

    Time frame: Baseline up to 2 weeks and 3 months

    naming subtest from Aachener Aphasie Test (0-120; higher scores=better abilities)

  11. Change in language impairment on Mini Language State Examination

    Time frame: Baseline up to 2 weeks and 3 months

    Mini Language State Examination Battery (higher scores=better abilities)

  12. Change in molecular biomarkers on neurogranin

    Time frame: Baseline up to 2 weeks

    neurogranin

  13. Change in imaging biomarkers on fMRI and fNIRS

    Time frame: Baseline up to 2 weeks

    fMRI and fNIRS

Sponsors and collaborators

Lead sponsor

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Other

Collaborators

  • Asst Degli Spedali Civili Di Brescia

Registry information

Official study title

The Effects of a Multimodal Approach for the Treatment of Primary Progressive Aphasia

Acronym: ACROSS

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 5, 2019
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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