N/A
N=37
tDCS Intervention in Primary Progressive Aphasia
Primary Progressive Aphasia · MCI · FTD
Bottom Line
View on ClinicalTrials.gov: NCT02606422 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Absolute Percent Change in Written Naming (Trained Items) — 39.4; 28.4; 33.1; 20.0 absolute percent change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active HD-tDCS plus Speech-Language Therapy (Device); Sham plus Speech-Language Therapy (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Percent Change in Written Naming (Trained Items) |
39.4; 28.4; 33.1; 20.0; 27.5; 11.7 | — |
| PRIMARY Absolute Percent Change in Written Naming (Untrained Items) |
14.6; 9.6; 15.6; 6.6; 17.3; 3.0 | — |
| PRIMARY Absolute Percent Change in Oral Naming (Trained Items) |
38.8; 26.9; 30; 21.3; 24.9; 15.3 | — |
| PRIMARY Absolute Percent Change in Oral Naming (Untrained Items) |
8.1; 8.9; 4.8; 7.9; 3.9; 2.6 | — |
| SECONDARY Change in Sentence Comprehension as Measured by the Subject Object Active Passive (SOAP) Test |
3.250; -0.412 | — |
| SECONDARY Change in Functional Connectivity |
-0.08; 0.02 | <.05 sig |
Summary
Primary progressive aphasia (PPA) is a neurodegenerative disease that affects first and foremost language abilities. Mild cognitive impairment (MCI) is slowly progressive decline in a single domain of cognition (e.g. language) not attributable to motor or sensory loss, without impediment of social or occupational function. MCI can be an early sign of neurodegenerative disease, or can be due to normal aging. When language is the prominent affected domain in MCI, the person may later meet criteria for PPA or may progress to the clinical syndrome of Alzheimer's dementia. Spelling, naming, and working memory (e.g. repetition) are among the language abilities affected early in the course of PPA or language-centered MCI, and different variants have distinct deficits in these domains. This research project investigates the behavioral and neuromodulatory effects of high definition transcranial direct current stimulation (HD-tDCS) during language therapy in PPA participants over time. Anodal HD-tDCS targeting the left inferior frontal gyrus (IFG) administered in combination with language therapy is expected to be more beneficial when compared to language therapy alone. It will 1) improve language performance or decrease rate of decline, 2) have better-sustained effects at 2 weeks and 2 months post-treatment, and 3) produce generalization to untrained language items and some other cognitive functions. Resting-state fMRI, diffusion tensor imaging (DTI), and volumetric data are also collected to investigate changes in functional brain connectivity associated with HD-tDCS in individuals with PPA. A better understanding of the therapeutic and neuromodulatory mechanisms of HD-tDCS as an adjunct to language therapy in PPA may have a significant impact on the development of effective therapies for PPA and MCI, and may offer insight into ways of impeding neurodegeneration that may improve patients' quality of life, as well as extend their ability to work and manage their affairs.
Eligibility Criteria
Inclusion Criteria
- Must be clinically diagnosed with semantic variant PPA (svPPA), non-fluent variant PPA (nfvPPA), or logopenic variant PPA (lvPPA), unclassifiable PPA, or MCI. Diagnosis will be based on neuropsychological testing, language testing (most commonly the Western Aphasia Battery), MRI and clinical assessment.
- Must be right-handed.
- Must be speakers of English.
- Must have at least 9th grade education.
Exclusion Criteria
- Uncorrected visual or hearing impairment by self report.
- Stroke/other premorbid neurological disorder affecting the brain.
- Any other language-based learning disorder other than PPA.
- Inability to follow directions for baseline tasks.
- Western Aphasia Battery Aphasia Quotient (AQ) <30 (indicating severe language impairment).
Exclusion Criteria for MRI Participation:
- Severe claustrophobia.
- Cardiac pacemakers or ferromagnetic implants.
- Pregnant women.
Data sourced from ClinicalTrials.gov (NCT02606422). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.