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

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ClinicalTrials.gov Identifier: NCT04187391
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : January 22, 2020
Sponsor:
Collaborator:
Azienda Ospedaliera Spedali Civili di Brescia
Information provided by (Responsible Party):
IRCCS Centro San Giovanni di Dio Fatebenefratelli

Tracking Information
First Submitted Date  ICMJE November 29, 2019
First Posted Date  ICMJE December 5, 2019
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE January 15, 2020
Estimated Primary Completion Date December 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2019)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Change in molecular biomarkers on neurogranin [ Time Frame: Baseline up to 2 weeks ]
    neurogranin
  • Change in imaging biomarkers on fMRI and fNIRS [ Time Frame: Baseline up to 2 weeks ]
    fMRI and fNIRS
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of a Multimodal Approach for the Treatment of Primary Progressive Aphasia
Official Title  ICMJE The Effects of a Multimodal Approach for the Treatment of Primary Progressive Aphasia
Brief 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Primary Progressive Aphasia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Active tDCS plus individual language training
    Active tDCS plus individual language training
    Interventions:
    • Device: Active tDCS
    • Behavioral: Language training
  • Active Comparator: placebo tDCS plus individual language training
    placebo tDCS plus individual language training
    Interventions:
    • Device: Placebo tDCS
    • Behavioral: Language training
  • Active Comparator: Active tDCS plus unstructured cognitive stimulation
    Active tDCS plus unstructured cognitive stimulation
    Interventions:
    • Device: Active tDCS
    • Behavioral: Unstructured cognitive training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 3, 2019)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2022
Estimated Primary Completion Date December 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rosa Manenti, PhD 00390303501457 rmanenti@fatebenefratelli.eu
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04187391
Other Study ID Numbers  ICMJE GR 2018 12365105
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party IRCCS Centro San Giovanni di Dio Fatebenefratelli
Study Sponsor  ICMJE IRCCS Centro San Giovanni di Dio Fatebenefratelli
Collaborators  ICMJE Azienda Ospedaliera Spedali Civili di Brescia
Investigators  ICMJE
Principal Investigator: Rosa Manenti, PhD IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
PRS Account IRCCS Centro San Giovanni di Dio Fatebenefratelli
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP