Speech-Language Treatment With Remotely Supervised Transcranial Direct Current Stimulation in Pri… (NCT05901233) | Clinical Trial Compass
By InvitationNot Applicable
Speech-Language Treatment With Remotely Supervised Transcranial Direct Current Stimulation in Primary Progressive Aphasia
United States10 participantsStarted 2023-07-10
Plain-language summary
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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
RS-LRT arm: Change in spoken naming
Timeframe: change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)
2
RS-VISTA arm: Change in script production accuracy
Timeframe: change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)