- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03728582
Rehabilitating and Decelerating Language Loss in Primary Progressive Aphasia With tDCS Plus Language Therapy
April 25, 2023 updated by: Johns Hopkins University
Rehabilitating and Decelerating Language Loss in Primary Progressive Aphasia With Transcranial Direct Current Stimulation (tDCS) Plus Language Therapy
People with Primary Progressive Aphasia (PPA) are is a debilitating disorder characterized by the gradual loss of language functioning, even though cognitive functioning is relatively well preserved until the advanced stages of the disease.
There are very few evidence-based treatment options available.
This study investigates the behavioral and neural effects of multiple consecutive tDCS sessions paired with language therapy targeting verbs in sentences with individuals with PPA.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Primary Progressive Aphasia (PPA) is a debilitating disorder characterized by the gradual loss of language functioning, even though cognitive functioning is relatively well preserved until the advanced stages of the disease.
There are three main PPA variants classified based on the pattern of language impairments and areas of atrophy, but anomia is present across all variants in the earliest stages.
While there is a significant amount of research investigating multiple treatment approaches for individuals with aphasia resulting from stroke, individuals with PPA have far fewer treatment options to choose from.
Recently, a growing body of literature of treatment in stroke-based aphasia have found promising results for pairing traditional language therapy with non-invasive neurostimulation via transcranial direct current stimulation (tDCS).
The small amount of studies of the effects of tDCS applied to left inferior frontal gyrus (IFG) in PPA also yield promising results that show tDCS can enhance generalization to untreated structures.
Research in stroke-based aphasia has also shown that language outcomes significantly improve when participants are treated with more complex language stimuli, because this treatment approach results in enhanced generalization.
For example, therapy that has participants build sentences around verbs has been found to improve word-level verb and noun naming.
The current proposal aims to investigate whether combining the benefits of tDCS while providing verb retrieval therapy that uses sentence building to improve word-level retrieval deficits, will enhance word retrieval deficits in PPA and slow the loss of language functioning.
It is hypothesized that Furthermore, the proposed study will investigate the atrophy patterns at baseline, to determine which atrophy patterns are predictive of improved word retrieval.
Specifically, this proposal aims: 1) to determine whether tDCS to left IFG coupled with therapy promoting verb retrieval within sentences improve noun and verb retrieval in treated and untreated items in individuals with PPA, and 2) To investigate which patterns of atrophy are predictive of maintenance and generalization of word-retrieval in individuals with PPA following tDCS+therapy vs. sham+therapy.
This proposed research will allow the investigators to evaluate the potential benefits and sustainability of tDCS in PPA, the generalization of trained items to untrained items, as well as the deceleration of language loss.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shannon M Sheppard, PhD
- Phone Number: 410-502-6045
- Email: sheppard@jhmi.edu
Study Contact Backup
- Name: Argye E Hillis, MD, MS
- Phone Number: 410-614-2381
- Email: argye@jhmi.edu
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosis of PPA, based on the PPA criteria and presence of naming deficits
- Capable of giving informed consent or indicating another to provide informed consent
- 18 years of age to 100 years of age..
Exclusion Criteria:
- Did not speak English before the age of five
- Less than 10 years of education
- Severe naming deficits
- Significant history of drug or alcohol abuse
- History of psychiatric or neurological problems affecting the brain (besides PPA)
- Has experienced seizures during the previous 12 months
- History of brain surgery or any metal in the head
- Uncorrected visual loss or hearing loss by self-report
- Use of medications that lower the seizure threshold (e.g., methylphenidate) or use of N-Methyl-D-aspartate (NMDA) receptor antagonists (e.g., memantine)
- Scalp sensitivity (per participant report)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
Language therapy will be verb naming therapy in a sentence context.
This will be followed by sham tDCS plus speech-language therapy after a 2 month washout period.
|
Sham tDCS stimulation is provided to the left inferior frontal gyrus (IFG) using a tDCS device.
Speech-language therapy will be verb naming therapy in a sentence context.
1-2 milliamps (mA) of Anodal tDCS stimulation is induced between 5cm X5 cm saline soaked sponges where one sponge is placed on the left inferior frontal gyrus (IFG).
The stimulation will be delivered at an intensity of 1-2 mA in a ramp-like fashion for a maximum of 20 minutes.
Speech-language therapy will be verb naming therapy in a sentence context.
Other Names:
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Sham Comparator: Sham plus Speech-Language Therapy
Sham tDCS will be applied at the beginning of 45min speech-language therapy session.
Language therapy will be oral and written naming.
Language therapy will be verb naming therapy in a sentence context.
This will be followed by active tDCS plus speech-language therapy after a 2 month washout period.
|
Sham tDCS stimulation is provided to the left inferior frontal gyrus (IFG) using a tDCS device.
Speech-language therapy will be verb naming therapy in a sentence context.
1-2 milliamps (mA) of Anodal tDCS stimulation is induced between 5cm X5 cm saline soaked sponges where one sponge is placed on the left inferior frontal gyrus (IFG).
The stimulation will be delivered at an intensity of 1-2 mA in a ramp-like fashion for a maximum of 20 minutes.
Speech-language therapy will be verb naming therapy in a sentence context.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Accuracy of Naming Trained Verbs (0 to 15, Higher Scores Reflect Better Naming Abilities) as Assessed by Object and Action Naming Battery (OANB)
Time Frame: Baseline, and 4-7 weeks after treatment begins
|
To determine whether tDCS + language therapy will improve naming performance of participants with Primary Progressive Aphasia more effectively than language therapy alone (the sham condition).
The primary outcome variable will be trained verbs on the Object and Action Naming battery (OANBtrained).
The OANB has 262 items, scored from 0 to 262, with higher scores on the OANB reflecting better naming abilities.
The OANB includes 100 verbs (15 trained, 85 untrained) and 162 nouns.
|
Baseline, and 4-7 weeks after treatment begins
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Functional Communication Skills as Assessed by the Functional Assessment of Communication Skills for Adults (ASHA FACS)
Time Frame: Baseline, and 4-7 weeks after treatment begins
|
The ASHA FACS will be administered pre-treatment and post-treatment to evaluate changes in functional communication skills.
The ASHA FACS is used for measuring the functional communication of adults with speech, language, and cognitive communication disorders.
The Communicative Independence Scale will be used, which is rated on a 7-point scale ranging from 1 "does not perform the behavior" to 7 "does perform the behavior".
The scores on the Communicative Independence Scale range from a low score of 1 to a high score of 7. A higher score on this subscale indicates better ability to communicate independently.
|
Baseline, and 4-7 weeks after treatment begins
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Change in Functional Communication Skills as Assessed by the Functional Assessment of Communication Skills for Adults (ASHA FACS)
Time Frame: Baseline, and 2 months after treatment ends
|
The ASHA FACS will be administered pre- treatment and post treatment to evaluate changes in functional communication skills.
The ASHA FACS is used for measuring the functional communication of adults with speech, language, and cognitive communication disorders.
The Communicative Independence Scale will be used, which is rated on a 7-point scale ranging from 1 "does not perform the behavior" to 7 "does perform the behavior".
The scores on the Communicative Independence Scale range from a low score of 1 to a high score of 7. A higher score on this subscale indicates better ability to communicate independently.
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Baseline, and 2 months after treatment ends
|
Change in Accuracy of Naming Untrained Verbs (0 to 85, Higher Scores Reflect Better Naming Abilities) and Nouns (0 to 162, Higher Scores Reflect Better Naming Abilities) as Assessed by Object and Action Naming Battery
Time Frame: Baseline, and 4-7 weeks after treatment begins
|
To determine whether tDCS + language therapy will improve naming performance of participants with Primary Progressive Aphasia more effectively than language therapy alone (the sham condition).
The OANB has 262 items, scored from 0 to 262, with higher scores on the OANB reflecting better naming abilities.
There are 100 verbs (15 trained, 85 untrained) on the OANB, and 162 nouns.
|
Baseline, and 4-7 weeks after treatment begins
|
Change in Accuracy of Naming Trained Verbs (0 to 15, Higher Scores Reflect Better Naming Abilities) as Assessed by Object and Action Naming Battery
Time Frame: Baseline, and 2 months after treatment ends
|
To determine whether tDCS + language therapy will improve naming performance of participants with Primary Progressive Aphasia more effectively than language therapy alone (the sham condition).
The OANB has 262 items, scored from 0 to 262, with higher scores on the OANB reflecting better naming abilities.
There are 100 verbs (15 trained, 85 untrained) and 162 nouns on the OANB.
|
Baseline, and 2 months after treatment ends
|
Change in Accuracy of Naming Untrained Verbs (0 to 85, Higher Scores Reflect Better Naming Abilities) and Untrained Nouns (0 to 162, Higher Scores Reflect Better Naming Abilities) as Assessed by Object and Action Naming Battery
Time Frame: Baseline, and 2 months after treatment ends
|
To determine whether tDCS + language therapy will improve naming performance of participants with Primary Progressive Aphasia more effectively than language therapy alone (the sham condition).
The OANB has 262 items, scored from 0 to 262, with higher scores on the OANB reflecting better naming abilities.
There are 100 verbs (15 trained, 85 untrained) on the OANB, and 162 nouns.
|
Baseline, and 2 months after treatment ends
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shannon M Sheppard, PhD, Johns Hopkins University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2018
Primary Completion (Actual)
March 30, 2022
Study Completion (Actual)
March 30, 2022
Study Registration Dates
First Submitted
October 31, 2018
First Submitted That Met QC Criteria
October 31, 2018
First Posted (Actual)
November 2, 2018
Study Record Updates
Last Update Posted (Actual)
April 27, 2023
Last Update Submitted That Met QC Criteria
April 25, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Dementia
- Language Disorders
- Communication Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Aphasia
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
Other Study ID Numbers
- IRB00174879
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Upon completion of the projects and dissemination of primary study results, the de-identified analysis data files will be made available to the public, along with the final version of the study protocol, the data dictionary, and brief instructions ("read me" file).
The public use data files and the accompanying documents will be made available through the National Technical Information Service (NTIS).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Progressive Aphasia
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Massachusetts General HospitalCompletedLogopenic Variant Primary Progressive Aphasia | Non-Fluent Primary Progressive AphasiaUnited States
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University of Texas at AustinUniversity of California, San Francisco; National Institute on Deafness and...Active, not recruitingPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Semantic Memory Disorder | Nonfluent Aphasia, Progressive | Aphasia, ProgressiveUnited States
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Johns Hopkins UniversityNational Institute on Aging (NIA)RecruitingPrimary Progressive Aphasia | Logopenic Progressive Aphasia | Non-Fluent Primary Progressive AphasiaUnited States, Canada
-
Massachusetts General HospitalNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingLogopenic Variant Primary Progressive Aphasia | Non-fluent Variant Primary Progressive Aphasia | Semantic Variant Primary Progressive AphasiaUnited States
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Mayo ClinicNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingPrimary Progressive Aphasia | Apraxia of Speech | PPA | Non-fluent Aphasia | Primary Progressive Non-fluent AphasiaUnited States
-
University of British ColumbiaTerminatedPrimary Progressive Nonfluent AphasiaCanada
-
Axon Neuroscience SEUnknownPrimary Progressive Nonfluent AphasiaGermany
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Mayo ClinicCompletedPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Apraxia of Speech | Primary Progressive Nonfluent Aphasia | PPA | Non-fluent Aphasia | Progressive AphasiaUnited States
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Montreal Heart InstituteActive, not recruitingNeurodegenerative Diseases | Primary Progressive Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Non-fluent AphasiaCanada
-
Mayo ClinicRecruitingPrimary Progressive Aphasia | Apraxia of Speech | Primary Progressive Nonfluent Aphasia | Non-fluent AphasiaUnited States
Clinical Trials on Sham tDCS plus Speech-Language Therapy
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Johns Hopkins UniversityWithdrawn
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Johns Hopkins UniversityActive, not recruitingPrimary Progressive AphasiaUnited States
-
Johns Hopkins UniversityNational Institutes of Health (NIH); National Institute on Deafness and Other...RecruitingPrimary Progressive Aphasia | MCI | FTDUnited States
-
University of New MexicoNational Institutes of Health (NIH); National Institute of General Medical... and other collaboratorsRecruitingStroke | AphasiaUnited States
-
Casa Colina Hospital and Centers for HealthcareCompleted
-
Johns Hopkins UniversityNational Institute on Aging (NIA)RecruitingPrimary Progressive Aphasia | Logopenic Progressive Aphasia | Non-Fluent Primary Progressive AphasiaUnited States, Canada
-
Louisiana State University and A&M CollegeCompletedClinical Feasibility of Transcranial Direct Current Stimulation [tDCS] With Standard Aphasia TherapyStroke | AphasiaUnited States
-
University of ArizonaRecruitingPrimary Progressive AphasiaUnited States
-
Louisiana State University and A&M CollegeNot yet recruitingStroke | AphasiaUnited States
-
Johns Hopkins UniversityUniversity of South CarolinaCompleted