Remotely Supervised Transcranial Direct Current Stimulation (tDCS) for Primary Progressive Aphasia (PPA)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Complete 16 Out of 20 Study Visits
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Remotely Supervised tDCS and Word-Naming Practice
At each session, the tDCS device will deliver 2.0 mA electric current for 30 minutes over the left frontotemporal lobe with focus on the inferior frontal gyrus (IFG). Participants will receive 20 intervention sessions over the course of the interventional period (4 weeks) on weekdays (Monday-Friday). During the stimulation period, participants will engage in a picture-naming exercise as guided by the study tDCS clinicians.
干预措施: Transcranial Direct Current Stimulation (tDCS) (Device)
Remotely Supervised tDCS and Word-Naming Practice
At each session, the tDCS device will deliver 2.0 mA electric current for 30 minutes over the left frontotemporal lobe with focus on the inferior frontal gyrus (IFG). Participants will receive 20 intervention sessions over the course of the interventional period (4 weeks) on weekdays (Monday-Friday). During the stimulation period, participants will engage in a picture-naming exercise as guided by the study tDCS clinicians.
干预措施: Word-Naming Activity (Behavioral)
结局指标
主要结局
Percentage of Participants Who Complete 16 Out of 20 Study Visits
时间窗: Week 4
Measure of feasibility.
次要结局
- Number of Trained Language Probes at Treatment End(Week 4)
- Number of Untrained Language Probes at Treatment End(Week 4)
- Change in Aphasia Communication Outcome Measure (ACOM) Score(Baseline, Month 6)
- Change in Stroke and Aphasia Quality of Life-39 Item (SAQOL-39) Score(Baseline, Month 6)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Social Roles and Activities Score(Baseline, Month 6)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health Score(Baseline, Month 6)
- Change in Quick Aphasia Battery (QAB) Score(Baseline, Month 6)
- Change in Boston Naming Test (BNT)-Short Form Score(Baseline, Month 6)
- Change in Controlled Oral Word Association Test (COWAT) Score(Baseline, Month 6)