Enhancing Language Function in Primary Progressive Aphasia
NCT ID: NCT04920318
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2021-08-30
2027-06-15
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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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
tDCS + language therapy
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.
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
sham TDCS + language therapy
sham control will be applied with language therapy to the same regions as active TDCS.
Interventions
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tDCS + language therapy
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.
sham TDCS + language therapy
sham control will be applied with language therapy to the same regions as active TDCS.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* speech-language deficit arising from PPA
* native speaker of English Language or equivalent
* adequate vision (normal or corrected to normal)
* adequate hearing
Exclusion Criteria
* 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
45 Years
80 Years
ALL
No
Sponsors
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University of Arizona
OTHER
Responsible Party
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Principal Investigators
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Aneta Kielar, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Locations
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University of Arizona
Tucson, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2103570362
Identifier Type: -
Identifier Source: org_study_id