The Effects of a Multimodal Approach for the Treatment of PPA

NCT04187391 | Completed

• 1 other identifier: GR 2018 12365105
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Progressive Aphasia

Outcome Measures

Primary Outcomes (1)

• Change in naming test scores on Picture Naming Task

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

  Baseline up to 2 weeks and 3 months

Secondary Outcomes (13)

• Change in quality of life on Stroke and Aphasia Quality of Life

  Baseline up to 2 weeks and 3 months

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

  Baseline up to 2 weeks and 3 months

• Change in cognitive impairment on Mini Mental State Examination

  Baseline up to 2 weeks and 3 months

• Change in verbal long term memory on Story Recall

  Baseline up to 2 weeks and 3 months

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

  Baseline up to 2 weeks and 3 months

Study Arms (3)

Active tDCS plus individual language training

EXPERIMENTAL

Active tDCS plus individual language training

Device: Active tDCS; Behavioral: Language training

placebo tDCS plus individual language training

ACTIVE COMPARATOR

placebo tDCS plus individual language training

Device: Placebo tDCS; Behavioral: Language training

Active tDCS plus unstructured cognitive stimulation

ACTIVE COMPARATOR

Active tDCS plus unstructured cognitive stimulation

Device: Active tDCS; Behavioral: Unstructured cognitive training

Interventions

Active tDCS DEVICE

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

Active tDCS plus individual language training; Active tDCS plus unstructured cognitive stimulation

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.

placebo tDCS plus individual language training

Language training BEHAVIORAL

patients receive language training

Active tDCS plus individual language training; placebo tDCS plus individual language training

Unstructured cognitive training BEHAVIORAL

patients receive unstructured cognitive training.

Active tDCS plus unstructured cognitive stimulation

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Centro San Giovanni di Dio Fatebenefratelli: lead
• Asst Degli Spedali Civili Di Brescia: collaborator

Study Sites (1)

IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli

Brescia, BS, 25125, Italy

Location

MeSH Terms

Conditions

Aphasia, Primary Progressive

Interventions

Language Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Rosa Manenti, PhD

  IRCCS Istituto Centro San Giovanni di Dio- Fatebenefratelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: December 5, 2019
• Study Start: January 15, 2020
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Locations

IT (1)