NCT04920318 · University of Arizona
Enhancing Language Function in Primary Progressive Aphasia
(PPA)
What this study is about
This study's goal is to use non-invasive brain stimulation (NBS) techniques to treat language impairment associated with Primary Progressive Aphasia (PPA).
View original scientific description
This study's goal is to use non-invasive brain stimulation (NBS) techniques to treat language impairment associated with Primary Progressive Aphasia (PPA). The purpose of this study is to combine behavioral language intervention with individualized noninvasive brain stimulation techniques, called transcranial direct current stimulation (tDCS) to help the brain reorganize around damage and improve language functions.
Interventions
COMBINATION_PRODUCT
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.
COMBINATION_PRODUCT
sham TDCS + language therapy
sham control will be applied with language therapy to the same regions as active TDCS.
Primary outcome measures
Mean change from baseline scores on the Arizona Phonological Battery
Time frame: through study completion, an average of 1 year
Mean change from baseline scores on the Arizona Phonological Battery: Minimum score = 0; maximum = 100%; higher scores indicate better outcome
Mean change from baseline scores on the naming task
Time frame: through study completion, an average of 1 year
Mean change from baseline scores on the Boston Naming Test: Min score = 0; Max = 60; higher scores indicate better outcome
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
change on on the probe task from before the session; Min =0; Max = 100%; higher scores indicate better outcome
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- metallic cardiac pumps
- 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
- 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
Where
- Tucson, Arizona
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 29, 2024 · Source of record for eligibility and locations