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tDCS Intervention in Primary Progressive Aphasia

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ClinicalTrials.gov Identifier: NCT02606422
Recruitment Status : Recruiting
First Posted : November 17, 2015
Last Update Posted : September 3, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Primary progressive aphasia (PPA) is a neurodegenerative disease that affects first and foremost language abilities. Mild cognitive impairment (MCI) is slowly progressive decline in a single domain of cognition (e.g. language) not attributable to motor or sensory loss, without impediment of social or occupational function. MCI can be an early sign of neurodegenerative disease, or can be due to normal aging. When language is the prominent affected domain in MCI, the person may later meet criteria for PPA or may progress to the clinical syndrome of Alzheimer's dementia. Spelling, naming, and working memory (e.g. repetition) are among the language abilities affected early in the course of PPA or language-centered MCI, and different variants have distinct deficits in these domains. This research project investigates the behavioral and neuromodulatory effects of transcranial direct current stimulation (tDCS) during language therapy in PPA participants over time. Anodal tDCS targeting the left inferior frontal gyrus (IFG) administered in combination with language therapy is expected to be more beneficial when compared to language therapy alone. It will 1) improve language performance or decrease rate of decline, 2) have better-sustained effects at 2 weeks and 2 months post-treatment, and 3) produce generalization to untrained language items and some other cognitive functions. Resting-state fMRI, diffusion tensor imaging (DTI), and volumetric data are also collected to investigate changes in functional brain connectivity associated with tDCS in individuals with PPA. A better understanding of the therapeutic and neuromodulatory mechanisms of tDCS as an adjunct to language therapy in PPA may have a significant impact on the development of effective therapies for PPA and MCI, and may offer insight into ways of impeding neurodegeneration that may improve patients' quality of life, as well as extend their ability to work and manage their affairs.

Condition or disease Intervention/treatment Phase
Primary Progressive Aphasia MCI FTD Device: Active tDCS plus Speech-Language Therapy Device: Sham plus Speech-Language Therapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Transcranial Direct Current Stimulation (tDCS) in Spoken and Written Production in Primary Progressive Aphasia (PPA)
Study Start Date : April 2013
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : May 2020


Arm Intervention/treatment
Experimental: Active tDCS plus Speech-Language Therapy
Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min.
Device: Active tDCS plus Speech-Language Therapy
Stimulation will be delivered by a battery-driven constant current stimulator. The electrical current will be administered to a pre-specified region of the brain (inferior frontal gyrus). The stimulation will be delivered at an intensity of 2mA (estimated current density 0.04 mA/cm2; estimated total charge 0.048C/cm2) in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be oral and written naming.

Sham Comparator: Sham plus Speech-Language Therapy
Sham tDCS will be applied at the beginning of 45min speech-language therapy session.
Device: Sham plus Speech-Language Therapy
Speech-Language therapy will be administered during sham stimulation. Current will be administered in a ramp-line fashion but after the ramping the intensity will drop to 0 mA. Speech-language therapy will be oral and written naming.




Primary Outcome Measures :
  1. Change in oral naming (trained items) [ Time Frame: 35 weeks ]
    We will investigate any changes in performance from pre- to post-treatment levels of change in % accuracy in trained items.

  2. Change in written naming (trained items) [ Time Frame: 35 weeks ]
    We will investigate any changes in performance from pre- to post-treatment levels of change in % accuracy in trained items.

  3. Change in oral naming (untrained items) [ Time Frame: 35 weeks ]
    We will investigate any changes in performance from pre- to post-treatment levels of change in % accuracy in untrained items.

  4. Change in written naming (untrained items) [ Time Frame: 35 weeks ]
    We will investigate any changes in performance from pre- to post-treatment levels of change in % accuracy in untrained items.


Secondary Outcome Measures :
  1. Change in other language and cognitive task performances (global cognitive changes) [ Time Frame: 35 weeks ]
    Secondary outcome variables will be generalization of the improvement induced by the stimulation of the IFG in other language and cognitive functions with the same neural substrates.

  2. Changes in functional connectivity [ Time Frame: 35 weeks ]
    Using rsfMRI, DTI, and volumetric imaging, we will investigate whether tDCS intervention will result in different changes in connectivity between the targeted area and other nodes in the "language network," also controlling for the effect of gray and white matter volume loss as covariates.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be clinically diagnosed with svPPA, nfvPPA or lvPPA, unclassifiable PPA, or MCI. Diagnosis will be based on neuropsychological testing, language testing (most commonly the Western Aphasia Battery), MRI and clinical assessment.
  • Must be right-handed.
  • Must be speakers of English.
  • Must have at least 9th grade education.

Exclusion Criteria:

  • Uncorrected visual or hearing impairment by self report.
  • Stroke/other premorbid neurological disorder affecting the brain.
  • Any other language-based learning disorder other than PPA.
  • Inability to follow directions for baseline tasks.
  • Western Aphasia Battery Aphasia Quotient (AQ) <30 (indicating severe language impairment).

Exclusion Criteria for MRI Participation:

  • Severe claustrophobia.
  • Cardiac pacemakers or ferromagnetic implants.
  • Pregnant women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606422


Contacts
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Contact: Kyrana Tsapkini, PhD 4107362940 tsapkini@jhmi.edu
Contact: Bronte Ficek bficek1@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21204
Contact: Kyrana Tsapkini, PhD    410-736-2940    tsapkini@jhmi.edu   
Contact: Bronte Ficek       bficek1@jhmi.edu   
Principal Investigator: Kyrana Tsapkini, PhD         
Sub-Investigator: Argye Hillis, MD         
Sponsors and Collaborators
Johns Hopkins University
National Institutes of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02606422     History of Changes
Other Study ID Numbers: NA_00071337
R01DC014475 ( U.S. NIH Grant/Contract )
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018

Keywords provided by Johns Hopkins University:
transcranial direct current stimulation (tDCS)
neurodegeneration
language therapy
Primary Progressive Aphasia (PPA)

Additional relevant MeSH terms:
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Speech Disorders
Aphasia
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Dementia
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dementia
Brain Diseases
Central Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases