Phase 2
Completed N=11
Remotely Supervised Transcranial Direct Current Stimulation (tDCS) for Primary Progressive Aphasia (PPA)
Primary Progressive Aphasia
Source: ClinicalTrials.gov NCT05615922 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Percentage of Participants Who Complete 16 Out of 20 Study Visits — 100 percentage of participants
Summary
The purpose of this study is to establish the feasibility of a program of remotely supervised transcranial direct current stimulation (RS-tDCS) paired with language skills practice for people living with the semantic or logopenic variants of primary progressive aphasia (PPA). There are currently no established standard-of-care treatments for PPA. This study will evaluate whether RS-tDCS combined with language skills practice is a feasible study design for individuals with PPA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Complete 16 Out of 20 Study Visits |
100 | — |
| SECONDARY Number of Trained Language Probes at Treatment End |
25.1 | — |
| SECONDARY Number of Untrained Language Probes at Treatment End |
20.2 | — |
| SECONDARY Change in Aphasia Communication Outcome Measure (ACOM) Score |
0.74 | — |
| SECONDARY Change in Stroke and Aphasia Quality of Life-39 Item (SAQOL-39) Score |
-0.07 | — |
| SECONDARY Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Social Roles and Activities Score |
-1.2 | — |
| SECONDARY Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health Score |
0.87 | — |
| SECONDARY Change in Quick Aphasia Battery (QAB) Score |
0.14 | — |
| SECONDARY Change in Boston Naming Test (BNT)-Short Form Score |
1.6 | — |
| SECONDARY Change in Controlled Oral Word Association Test (COWAT) Score |
1.4 | — |
Eligibility Criteria
Inclusion Criteria
- Primary progressive aphasia diagnosis (logopenic or semantic variant)
- Peabody Picture Vocabulary Test (PPVT) score < -1.0 SD, serving as a literacy proxy for premorbid cognitive ability and ensuring English language fluency sufficient for participation in the study procedures.
- WAIS-IV Matrix Reasoning T score < 20, serving as an index of current general cognitive functioning to exclude those with severe cognitive impairment
- Stable and continuous access to internet service, email (WiFi "hotspot" to be provided if needed)
- Fluent in English language (due to outcomes validated in English versions only)
Exclusion Criteria
- Disorder other than PPA known to cause language dysfunction
- Diagnosis of nonfluent/agrammatic subtype of primary progressive aphasia
- History of traumatic brain injury
- Uncontrolled seizure disorder and/or recent (<5 years) history of seizure
- Metal implants in the head or neck
- Any skin disorder or skin sensitive area near stimulation locations
- Pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT05615922). 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. Informational only — not medical advice.