Enhancing Language Function in Primary Progressive Aphasia

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT04920318
Status
Recruiting
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Conditions

  • Primary Progressive Aphasia

Eligibility Criteria

Sex
ALL
Age
45 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • tDCS + language therapy — COMBINATION_PRODUCT
    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 — COMBINATION_PRODUCT
    sham control will be applied with language therapy to the same regions as active TDCS.

Study Details

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.

Key Dates

Start date
Aug 30, 2021
Status verified
Nov 2024
Primary completion
Dec 30, 2026
Completion
Jun 15, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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
  • 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

Primary Outcome Measure

Mean change from baseline scores on the Arizona Phonological Battery [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85721-0071
Aneta Kielar, PhD
[email protected]
520-488-3791

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By research site
University of Arizona· Tucson, AZ

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