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Completed

NCT Number: NCT03805659

HDtDCS in Logopenic Variant PPA: Effects on Language and Neural Mechanisms

This study aims to evaluate the effectiveness of a therapy called High-Definition Transcranial Direct Current Stimulation (HD-tDCS) for the treatment of the language deficits experienced by people with a type of Primary Progressive Aphasia. This study uses a combination of brain imaging, language assessment, language training sessions, and HD-tDCS therapy as well as placebo therapy sessions.

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Key information

About this study

The logopenic variant of Primary Progressive Aphasia (lvPPA) is an untreatable neurodegenerative disorder that is often referred to as the 'language form' of Alzheimer's Disease (AD). Transcranial Direct Current Stimulation (tDCS) has emerged as a safe and potentially effective tool that appears to enhance language production when delivered during language training. This technology provides a critical opportunity to conduct disease intervention.

In this study, the investigators will test the hypothesis that High-Definition tDCS (HD-tDCS) will improve performance on language tasks by increasing functional connectivity and by regulating abnormal neuronal oscillatory patterns. The rationale for this project is that a determination of the therapeutic efficacy and the associated neural mechanisms of HD-tDCS in lvPPA is likely to offer a scientific framework whereby new stimulation parameters, conditions, and target sites can be deciphered.

This study will test the hypothesis that HD-tDCS will improve performance on language tasks by increasing functional connectivity and by regulating abnormal neuronal oscillatory patterns. The language performance and functional connectivity changes will be determined in a randomized, double-blind, sham-controlled crossover manner, in which a stimulation of up to 2mA in the targeted cortical tissue or sham is administered to 20 lvPPA subjects age 45 years and older. The order of treatments is counterbalanced in a within-subject crossover design. In brief, study participants will receive sham during one treatment period and stimulation during the other treatment period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with language variant Primary Progressive Aphasia (lvPPA) subtype, defined as either clinical lvPPA or imaging-supported lvPPA in accordance with the most recent diagnostic criteria (Mesulam., 2001; Gorno-Tempini et al., 2011).
  • Fluent in English.
  • 45 years of age or older.
  • Structural brain MRI performed within 3 years prior to enrollment.

Exclusion criteria

  • Severe cognitive, auditory or visual impairments that would preclude cognitive testing.
  • Presence of major untreated or unstable psychiatric disease.
  • A chronic medical condition that is not treated or is unstable.
  • The presence of cardiac stimulators or pacemakers.
  • Any metal implants in the skull
  • Contraindications to MRI
  • History of seizures
  • History of dyslexia or other developmental learning disabilities.

Treatment and study plan

HD-tDCS

Device

High-Dose transcranial Direct Current Stimulation

Other names: Soterix MXN-9 High-Definition stimulator

SHAM

Device

Sham sessions (no electric current)

Primary outcomes

  1. Determine Changes in Language Performance After Stimulation Sessions

    Time frame: Language performance was assessed before and after 2-week intervention and during washout periods

    Language performance as assessed at baseline and post-stimulation procedure

Secondary outcomes

  1. Determine the Resting State Language Network-level Changes in Left TPC Functional Connectivity.

    Time frame: Language network resting state changes were assessed before and after 2-week intervention and during washout periods

    Language network resting state changes after stimulation procedure

  2. Determine the Neuronal Frequency Distribution and Connectivity Measures Associated With the Left TPC as Assessed by MEG.

    Time frame: Resting-state neuronal frequencies and synchronizations changes were assessed before and after 2-week intervention and during washout periods

    Resting-state neuronal frequencies and synchronizations changes after stimulation procedure

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

High-Definition Transcranial Direct Current Stimulation (HD-tDCS) in Logopenic Variant Primary Progressive Aphasia (lvPPA): Effects on Language and Neural Mechanisms

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 16, 2019
Registry last updated
Jun 11, 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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