Clinical trial NCT05615922: Remotely Supervised Transcranial Direct Current Stimulation (tDCS) for Primary Progressive Aphasia (PPA)
Official title: Remotely Supervised Transcranial Direct Current Stimulation (tDCS) for Primary Progressive Aphasia (PPA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Progressive Aphasia
Keywords: Transcranial Direct Current Stimulation (tDCS)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 11
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Primary progressive aphasia diagnosis (logopenic or semantic variant)
2. 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.
3. WAIS-IV Matrix Reasoning T score \< 20, serving as an index of current general cognitive functioning to exclude those with severe cognitive impairment
4. Stable and continuous access to internet service, email (WiFi "hotspot" to be provided if needed)
5. Fluent in English language (due to outcomes validated in English versions only)

Exclusion Criteria:

1. Disorder other than PPA known to cause language dysfunction
2. Diagnosis of nonfluent/agrammatic subtype of primary progressive aphasia
3. History of traumatic brain injury
4. Uncontrolled seizure disorder and/or recent (\<5 years) history of seizure
5. Metal implants in the head or neck
6. Any skin disorder or skin sensitive area near stimulation locations
7. Pregnant or breastfeeding

Primary outcomes:
measure: Percentage of Participants Who Complete 16 Out of 20 Study Visits
timeFrame: Week 4
Secondary outcomes:
measure: Number of Trained Language Probes at Treatment End
timeFrame: Week 4
measure: Number of Untrained Language Probes at Treatment End
timeFrame: Week 4
measure: Change in Aphasia Communication Outcome Measure (ACOM) Score
timeFrame: Baseline, Month 6
measure: Change in Stroke and Aphasia Quality of Life-39 Item (SAQOL-39) Score
timeFrame: Baseline, Month 6
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Social Roles and Activities Score
timeFrame: Baseline, Month 6
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health Score
timeFrame: Baseline, Month 6
measure: Change in Quick Aphasia Battery (QAB) Score
timeFrame: Baseline, Month 6
measure: Change in Boston Naming Test (BNT)-Short Form Score
timeFrame: Baseline, Month 6
measure: Change in Controlled Oral Word Association Test (COWAT) Score
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Leigh Charvet, PhD
role: PRINCIPAL_INVESTIGATOR
References: