Investigating the Benefits of Remotely-Supervised Neuromodulation In Primary Progressive Aphasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Maya Henry
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Change in spoken naming
研究概览
简要总结
The goal of this clinical trial is to learn whether home-based brain stimulation combined with virtual speech-language therapy can improve communication abilities in adults with logopenic variant primary progressive aphasia (lvPPA), a language disorder most often caused by Alzheimer's disease.
The main questions the study aims to answer are:
- Is combining remotely supervised transcranial direct current stimulation (tDCS) with virtual speech-language therapy feasible and acceptable for people with lvPPA?
- Does this combined treatment lead to improvements in communication compared to speech-language therapy with sham (placebo) stimulation?
- Do individual brain characteristics help predict who benefits most from this treatment?
Researchers will compare participants who receive active tDCS plus virtual speech-language therapy to participants who receive sham (placebo) tDCS plus virtual speech-language therapy to see if active brain stimulation enhances communication outcomes.
Participants will:
- Complete speech-language therapy sessions delivered by video visit.
- Receive either active or sham tDCS that is remotely supervised and completed at home.
- Complete language and cognitive testing before and after treatment.
- Undergo brain imaging and other assessments to help understand treatment response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets diagnostic criteria for primary progressive aphasia (PPA)
- •Meets diagnostic criteria for logopenic variant PPA
- •Attains score of 15 or higher on the Mini-Mental State Examination
- •Has adequate hearing and vision (with hearing or vision aids, if needed)
- •Is able to travel to research site and undergo MRI brain scan
- •Has access to high speed internet and basic experience using a computer and the internet
- •Is a fluent speaker of English
- •Has a study partner who can co-enroll in the study, attend pre-treatment training at the research site, and be present for teleconference meetings, as needed
排除标准
- •Speech and language deficits better accounted for by another neurological disorder
- •Does not meet diagnostic criteria for logopenic variant PPA
- •Scores less than 15 on the Mini-Mental State Examination
- •Does not have a study partner who can co-enroll in the study
- •Has contraindications for tDCS or MRI scan (History of seizures, head injury, craniotomy, skull surgery or fracture; History of severe or frequent migraines; Metallic implant in head or any metal in head; Pacemaker or cardioverter-defibrillator or any other stimulator; Chronic skin problems; Pregnancy)
- •Has a history of stroke, epilepsy, or significant brain injury
研究组 & 干预措施
Language Therapy with Sham Stimulation
Participants will receive virtual language therapy in conjunction with sham remotely-supervised transcranial direct current stimulation.
干预措施: Remotely Supervised Transcranial Direct Current Stimulation - Sham (Device)
Language Therapy with Active Stimulation
Participants will receive virtual language therapy in conjunction with active remotely-supervised transcranial direct current stimulation.
干预措施: Lexical Retrieval Cascade Treatment (Behavioral)
Language Therapy with Active Stimulation
Participants will receive virtual language therapy in conjunction with active remotely-supervised transcranial direct current stimulation.
干预措施: Remotely Supervised Transcranial Direct Current Stimulation- Active (Device)
Language Therapy with Sham Stimulation
Participants will receive virtual language therapy in conjunction with sham remotely-supervised transcranial direct current stimulation.
干预措施: Lexical Retrieval Cascade Treatment (Behavioral)
结局指标
主要结局
Change in spoken naming
时间窗: change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)
Change in percent correctly named trained/untrained pictures
次要结局
- Change on Communication Confidence Rating Scale for Aphasia(change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham))
- Change on Aphasia Impact Questionnaire(change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham))
- Theoretical Framework of Acceptability Questionnaire(one month after onset of treatment)
- Acceptability and Perception of Change Survey(one month after onset of treatment)
研究者
Maya Henry
Associate Professor, Associate Dean for Research
University of Texas at Austin