Telerehabilitation With Remotely-Supervised tDCS in Progressive Aphasia
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- RS-LRT arm: Change in spoken naming
研究概览
简要总结
Primary progressive aphasia (PPA) is a disorder characterized by gradual decline in speech-language ability caused by underlying neurodegenerative disease. PPA is a devastating condition that can affect adults as young as their 50's, depriving them of the ability to communicate and function in society. Along with Alzheimer's Disease and other Alzheimer's Disease Related Dementias (AD/ADRD), PPA is now identified earlier and with greater precision. Increasingly, patients and families seek options for behavioral and neuromodulatory treatments to address PPA's devastating effects on communication, prolong speech-language skills, and maximize quality of life. Studies have documented the robust benefits of speech-language telerehabilitation methods for persons with PPA, with in-home treatment resulting in immediate and long-term benefits. This investigation aims to further enhance the potency of these treatment approaches by pairing them with tailored neuromodulatory intervention that targets critical brain networks supporting treatment in each clinical subtype of PPA. The study will evaluate the feasibility and preliminary benefit of home-based transcranial direct current stimulation (tDCS) combined with evidence-based speech-language telerehabilitation methods. tDCS will be delivered to patients in their own homes and site of stimulation will be tailored for each clinical subtype of PPA. This project has the potential to enhance clinical management and rehabilitation for individuals with PPA by establishing the benefit of behavioral and neuromodulatory treatment that is neurobiologically-motivated and accessible for patients and families.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The order of administration for active and sham stimulation phases will be masked for the participant, study partner, study clinician, and primary investigator.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meets diagnostic criteria for PPA
- •Meets diagnostic criteria for a specific variant of PPA
- •Score of 20 or higher on the Mini-Mental State Examination
- •Adequate hearing and vision (with hearing or vision aids, if needed)
- •Has a study partner that can co-enroll in the study and attend pre-treatment training as well as continue to be present for weekly teleconference meetings
- •Able and willing to undergo MRI brain scan
- •Access to high speed internet
排除标准
- •Speech and language deficits better accounted for by another neurological disorder
- •Does not meet diagnostic criteria for a specific variant of PPA
- •Score of less than 20 on the Mini-Mental State Examination
- •Does not have a study partner who can co-enroll in the study
- •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)
- •History of stroke, epilepsy, or significant brain injury
结局指标
主要结局
RS-LRT arm: 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
RS-VISTA arm: Change in script production accuracy
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 correct, intelligible, scripted words produced for trained/untrained scripts
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))
- Client Satisfaction Questionnaire(four months after treatment onset)
- Remotely-supervised Transcranial Direct Current Stimulation (RS-tDCS) Survey(four months after onset of treatment)
- Care Partner Survey(four months after onset of treatment)
研究者
Maya Henry
Associate Professor of Speech, Language and Hearing Sciences
University of Texas at Austin