An interventional study of tDCS + language therapy and sham TDCS + language therapy in Primary Progressive Aphasia, sponsored by University of Arizona. Recruiting at 1 site in United States. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by University of Arizona · Not applicable, Interventional, and Treatment
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.
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
365 studies on the registry are indexed under Aphasia; 89 are open to participants now.
This study's planned enrollment of 20 is below the median of 30 across 316 interventional studies indexed under Aphasia.
Browse Aphasia studies →University of Arizona is the lead sponsor of 466 studies on the registry; 87 are open to participants now.
Of its 47 completed or terminated interventional studies of FDA-regulated products, 29 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Combination Product: tDCS + language therapy
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
Combination Product: sham 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.
Also known as: active tDCS, transcranial direct current simulation (tDCS)
sham control will be applied with language therapy to the same regions as active TDCS.
Also known as: sham transcranial direct current simulation (tDCS)
Mean change from baseline scores on the Arizona Phonological Battery
Mean change from baseline scores on the Arizona Phonological Battery: Minimum score = 0; maximum = 100%; higher scores indicate better outcome
Time frame: through study completion, an average of 1 year
Mean change from baseline scores on the naming task
Mean change from baseline scores on the Boston Naming Test: Min score = 0; Max = 60; higher scores indicate better outcome
Time frame: through study completion, an average of 1 year
Mean change from baseline scores on the language probe task before and after each session
change on on the probe task from before the session; Min =0; Max = 100%; higher scores indicate better outcome
Time frame: through study completion, an average of 1 year
Plan to share: No
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