Clinical trial NCT03805659: HDtDCS in Logopenic Variant PPA: Effects on Language and Neural Mechanisms
Official title: High-Definition Transcranial Direct Current Stimulation (HD-tDCS) in Logopenic Variant Primary Progressive Aphasia (lvPPA): Effects on Language and Neural Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Progressive Aphasia
Keywords: Adult
Primary Progressive Aphasia
High-definition Transcranial Direct Current Stimulation
HD-tDCS
Language
Logopenic
Magnetic Resonance Imaging
MRI
Magnetoencephalography
MEG
Brain
Aphasia
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 6
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a randomized, double-blind, sham-controlled trial in which stimulation or sham will be administered to 20 subjects over the age of 45 years, with the order of treatments counterbalanced in a within-subject crossover design. Stimulation and sham sessions last 20 minutes and occur for 10 days over a 2-week period.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine Changes in Language Performance After Stimulation Sessions
timeFrame: Language performance was assessed before and after 2-week intervention and during washout periods
Secondary outcomes:
measure: Determine the Resting State Language Network-level Changes in Left TPC Functional Connectivity.
timeFrame: Language network resting state changes were assessed before and after 2-week intervention and during washout periods
measure: Determine the Neuronal Frequency Distribution and Connectivity Measures Associated With the Left TPC as Assessed by MEG.
timeFrame: Resting-state neuronal frequencies and synchronizations changes were assessed before and after 2-week intervention and during washout periods
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: The Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: The Medical College of Wisconsin
name: Elias Granadillo
role: PRINCIPAL_INVESTIGATOR
References:
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