- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04920318
Enhancing Language Function in Primary Progressive Aphasia (PPA)
Enhancing Language Function in Primary Progressive Aphasia (PPA) With Transcranial Direct Current Stimulation (tDCS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Progressive Aphasia (PPA) is a neurodegenerative disorder that selectively affects language comprehension and/or production, with initial preservation of other cognitive domains. As tDCS has not been extensively studied in PPA, the investigators will measure both short- and long-term effects of stimulation in patients with this neurodegenerative disorder that affects specific language regions. Previous research suggests that neurostimulation with tDCS can safely induce changes in neural plasticity that can lead to long-term restoration of synaptic function. Thus, individually targeted stimulation to structurally preserved but dysfunctional regions may be able to produce behavioral improvements in primary progressive aphasia (PPA).
TDCS is a method of stimulating the brain that does not require any sedation or surgery. TDCS is a technique that sends a weak electrical current through the scalp to stimulate the brain areas below. The information gained from this research study will aid in the development of therapies to improve language in people with neurological conditions that affect language use.
TDCS will be applied over the activated area identified with the functional magnetic resonance imaging (fMRI) fMRI-localizer task. This approach will allow for individually optimized tDCS electrode placement. It will also account for potential inter-participant variability in the brain atrophy and language organization
Summary of study sequence and procedures:
Week 1: Baseline screening, language testing, one event-related brain potential (EEG-ERP) session Weeks 2: fMRI session to determine most effective treatment Weeks 3-4: tDCS with Language Treatment Part 1 Weeks 5 and 6: rest-period, post-treatment assessment Weeks 7 to 8: TDCS with Language Treatment Part 2 Weeks 9 and 10: rest period, post-treatment assessment 2-month follow-up, language assessment, one MRI scan, one EEG-ERP session
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aneta Kielar, PhD
- Phone Number: 15204883791
- Email: akielar@email.arizona.edu
Study Locations
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Arizona
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Tucson, Arizona, United States, 85721-0071
- Recruiting
- University of Arizona
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Contact:
- Aneta Kielar, PhD
- Phone Number: 520-488-3791
- Email: akielar@email.arizona.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- diagnosed with PPA by neurologist or speech-language pathologist
- speech-language deficit arising from PPA
- native speaker of English Language or equivalent
- adequate vision (normal or corrected to normal)
- adequate hearing
Exclusion Criteria:
- meeting (Diagnostic and Statistical Manual) DSM-IV criteria for Axis I mood, anxiety, psychotic or substance abuse disorders.
- highly magnetizable metallic implants, including certain dental work
- neurological disorders besides the ones of interest for the study (e.g., epilepsy)
- Multiple Sclerosis
- Parkinson's Disease
- contraindications for MRI
- pacemakers
- metallic cardiac pumps
- valves
- magnetic materials such as surgical clips, implanted electronic perfusion pumps, or any other condition that would preclude proximity to a strong magnetic field.
- clinically significant claustrophobia
- severe systemic disease (e.g., renal failure)
- poor health
- pregnancy
- epileptic activity in the past 12 months
- family history of epilepsy or other seizure disorders
- brain surgery in the past
- metallic skull plates or implants
- skin lesions or skull damage
- excessive use of alcohol or drugs
- premorbid psychiatric disease affecting communication
- severe non-linguistic cognitive disturbances impeding language therapy
Study Plan
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 |
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Experimental: active TDCS
During intervention excitatory/anodal tDCS will be administered alongside speech-language therapy 5 days a week for 2 weeks.
The exact location of the stimulation and electrode configuration will be targeted individually based on the optimal site identified in fMRI.
TDCS will be administered with NeurConn1 Channel DC- Stimulator Plus (neuroCare Group, München, Germany) according to established guidelines and procedures.
The active tDCS will be delivered for 20 minutes using sponge electrodes with a 30-s ramp-up and ramp-down period
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In this study fMRI-guided noninvasive neuromodulation will be applied, called Transcranial Direct Current Stimulation (tDCS) to the frontal and parietal brain regions that show reduced activation but still are structurally intact.
TDCS will be paired with personalized speech-language therapy to enhance language functions.
Other Names:
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Sham Comparator: sham TDCS
The sham will be administered alongside speech-language therapy 5 days a week for 2 weeks.
For sham, stimulation will be ramped up and then down to 0 milliamperes (mA) in the first minute of stimulation.
The sham parameters were chosen based on previous reports that the perceived sensations on the skin, such as tingling, fade out in the first 30 s of tDCS
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sham control will be applied with language therapy to the same regions as active TDCS.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean change from baseline scores on the Arizona Phonological Battery
Time Frame: through study completion, an average of 1 year
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Mean change from baseline scores on the Arizona Phonological Battery: Minimum score = 0; maximum = 100%; higher scores indicate better outcome
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through study completion, an average of 1 year
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Mean change from baseline scores on the naming task
Time Frame: through study completion, an average of 1 year
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Mean change from baseline scores on the Boston Naming Test: Min score = 0; Max = 60; higher scores indicate better outcome
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through study completion, an average of 1 year
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Mean change from baseline scores on the language probe task before and after each session
Time Frame: through study completion, an average of 1 year
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change on on the probe task from before the session; Min =0; Max = 100%; higher scores indicate better outcome
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through study completion, an average of 1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aneta Kielar, PhD, University of Arizona
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
- 2103570362
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
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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
-
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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University of British ColumbiaTerminatedPrimary Progressive Nonfluent AphasiaCanada
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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
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Mayo ClinicRecruitingPrimary Progressive Aphasia | Apraxia of Speech | Primary Progressive Nonfluent Aphasia | Non-fluent AphasiaUnited States
Clinical Trials on tDCS + language therapy
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Johns Hopkins UniversityNational Institute on Aging (NIA)RecruitingPrimary Progressive Aphasia | Logopenic Progressive Aphasia | Non-Fluent Primary Progressive AphasiaUnited States, Canada
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Johns Hopkins UniversityCompletedPrimary Progressive Aphasia | PPAUnited States
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Johns Hopkins UniversityWithdrawn
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The University of Hong KongCompleted
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Johns Hopkins UniversityActive, not recruitingPrimary Progressive AphasiaUnited States
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Casa Colina Hospital and Centers for HealthcareCompleted
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Johns Hopkins UniversityNational Institutes of Health (NIH); National Institute on Deafness and Other...CompletedPrimary Progressive Aphasia | MCI | FTDUnited States
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University of PennsylvaniaRecruiting
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IRCCS Centro San Giovanni di Dio FatebenefratelliFondazione Regionale per la Ricerca Biomedica (FRRB); IRCCS Fondazione Istituto... and other collaboratorsRecruitingPrimary Progressive AphasiaItaly
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University of New MexicoNational Institutes of Health (NIH); National Institute of General Medical... and other collaboratorsRecruitingStroke | AphasiaUnited States