Speech-Language Treatment With Remotely Supervised Transcranial Direct Current Stimulation in Primary Progressive Aphasia

Официальное название

Telerehabilitation With Remotely-Supervised tDCS in Progressive Aphasia

Обзор

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.

Вмешательства

• Устройство Remotely supervised Transcranial Direct Current Stimulation (RS-tDCS)
  tDCS is a type of non-invasive brain stimulation. 1.5 milliamp (mA) of current will be delivered via electrodes in saline-soaked sponges placed on the left side of the head and right upper arm. The stimulation will be delivered for 20 minutes, 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 sham tDCS (RS-sham-tDCS)
  tDCS is a type of non-invasive brain stimulation. During sham stimulation 1.5 milliamp (mA) of current will be delivered for a brief period and then turned off. Current will be delivered via electrodes in saline-soaked sponges placed on the left side of the head and right upper arm. Sham will be delivered for 20 minutes, 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.
• Поведенческое Lexical Retrieval Training (LRT)
  Participants work on producing spoken and written names of personally relevant target items using a self-cueing hierarchy. 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.
• Поведенческое Video Implemented Script Training in Aphasia (VISTA)
  Participants work on producing personally relevant scripts of 4-6 sentences in length. Length and complexity of scripts are individually tailored. The participant completes two (one hour each) teletherapy sessions per week with a clinician targeting clear and accurate script production, script memorization, and conversational usage of scripts. The participant completes 30 minutes of independent, computer-based practice 3 times per week, during which they speak in unison with a video/audio model

Первичные конечные точки

• RS-LRT arm: 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)]
• RS-VISTA arm: Change in script production accuracy [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 (5)

• 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)]
• Client Satisfaction Questionnaire [Срок оценки: four months after treatment onset]
• Remotely-supervised Transcranial Direct Current Stimulation (RS-tDCS) Survey [Срок оценки: four months after onset of treatment]
• Care Partner Survey [Срок оценки: four months after onset of treatment]

Критерии участия

Because PPA is a rare disease, the study aims to recruit all eligible participants with PPA who are referred to the Aphasia Research and Treatment Lab at the University of Texas (UT) Austin, the UT/Dell Medical School Department of Neurology, and the University of California at San Francisco (UCSF) Memory and Aging Center, as well as individuals with PPA from other clinical and research sites. The study will aim to include males, females, and transgender or non-binary individuals. Great efforts will be made to recruit participants from minority populations, subject to the limitation that participants need to be fluent speakers of English.

Критерии включения

• 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

Критерии исключения

• 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

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Memory and Aging Center, University of California, San Francisco — San Francisco
• University of Texas — Austin

Публикации

• Henry ML, Hubbard HI, Grasso SM, Mandelli ML, Wilson SM, Sathishkumar MT, Fridriksson J, Daigle W, Boxer AL, Miller BL, Gorno-Tempini ML. Retraining speech production and fluency in non-fluent/agrammatic primary progressive aphasia. Brain. 2018 Jun 1;141(6):1799-1814. doi: 10.1093/brain/awy101. PMID 29718131
• 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
• 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

Идентификаторы

NCT: NCT05901233 · STUDY00002453

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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