Remotely-supervised Neuromodulation in PPA

Официальное название

Investigating the Benefits of Remotely-Supervised Neuromodulation In Primary Progressive Aphasia

Обзор

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.

Вмешательства

• Поведенческое Lexical Retrieval Cascade Treatment
  Participants work on producing spoken and written names of personally-relevant target items. Treatment focuses on the use of strategies that capitalize on spared cognitive-linguistic abilities to support word retrieval. The participant completes two (one hour each) teletherapy sessions per week with a clinician plus 30 minutes of additional independent, computer-based practice exercises 3 times per week.
• Устройство Remotely Supervised Transcranial Direct Current Stimulation- Active
  tDCS is a type of non-invasive brain stimulation. 2.0 milliamp (mA) of current will be delivered via electrodes in saline-soaked sponges placed on the left and right sides of the head. The stimulation will last 20 minutes and will occur 5 times weekly, in the participant's home setting, while the participant engages in computer-delivered speech-language training. Sessions are monitored by study personnel.
• Устройство Remotely Supervised Transcranial Direct Current Stimulation - Sham
  tDCS is a type of non-invasive brain stimulation. 2.0 milliamp (mA) of current will be delivered via electrodes in saline-soaked sponges placed on the left and right sides of the head. In sham stimulation, current will be delivered for a brief period of time and then turned off. Sham stimulation will last 20 minutes and will occur 5 times weekly, in the participant's home setting, while the participant engages in computer-delivered speech-language training. Sessions are monitored by study person

Первичные конечные точки

• Change in spoken naming [Срок оценки: change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)]

Вторичные конечные точки (4)

• Change on Communication Confidence Rating Scale for Aphasia [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: one month after onset of treatment]
• Acceptability and Perception of Change Survey [Срок оценки: one month after onset of treatment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• UCSF Memory and Aging Cener — San Francisco
• University of Texas — Austin

Публикации

• Dial HR, Hinshelwood HA, Grasso SM, Hubbard HI, Gorno-Tempini ML, Henry ML. Investigating the utility of teletherapy in individuals with primary progressive aphasia. Clin Interv Aging. 2019 Feb 25;14:453-471. doi: 10.2147/CIA.S178878. eCollection 2019. PMID 30880927
• Henry ML, Hubbard HI, Grasso SM, Dial HR, Beeson PM, Miller BL, Gorno-Tempini ML. Treatment for Word Retrieval in Semantic and Logopenic Variants of Primary Progressive Aphasia: Immediate and Long-Term Outcomes. J Speech Lang Hear Res. 2019 Aug 15;62(8):2723-2749. doi: 10.1044/2018_JSLHR-L-18-0144. Epub 2019 Aug 7. PMID 31390290

Идентификаторы

NCT: NCT07260253 · RF1AG085565 · RF1AG085565

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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