Logopenic Progressive Aphasia (LPA), Logopenic Variant of Primary Progressive Aphasia (LPA), Logopenic Variant Primary Progressive Aphasia, Primary Progressive Aphasia(PPA), Progressive Aphasia, Progressive Aphasia in Alzheimer's Disease
Conditions
Keywords
lvPPA, PPA, logopenic variant PPA, transcranial direct-current stimulation, tDCS, neuromodulation, speech therapy, speech-language pathology, logopenic, teletherapy, remote, virtual
Brief summary
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.
Interventions
BEHAVIORALLexical 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.
DEVICERemotely 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.
DEVICERemotely 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 personnel.
Sponsors
Maya Henry
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants will be randomized into one of two arms: sham or active remotely-supervised transcranial direct current stimulation (RS-tDCS).
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in spoken naming | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 self-rating scale evaluating communication confidence in different settings for persons with aphasia. A higher score indicates greater confidence, with minimum and maximum values of 0 and 100. |
| 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) | Change on patient reported outcome measure for persons with aphasia; characterizes activities, participation and emotional state/wellbeing using a 5-point pictorial rating scale. A higher score indicates greater impact of aphasia, with minimum and maximum values of 0 and 84. |
| Theoretical Framework of Acceptability Questionnaire | one month after onset of treatment | The Theoretical Framework of Acceptability questionnaire is a measure developed for healthcare interventions to identify characteristics of interventions that may be improved or that were well-received. |
| Acceptability and Perception of Change Survey | one month after onset of treatment | The Acceptability and Perception of Change Survey characterizes perceived response to treatment. |
Countries
United States
Contacts
CONTACTAphasia Lab Research Coordinator
PRINCIPAL_INVESTIGATORMaya L Henry, PhD
University of Texas at Austin
PRINCIPAL_INVESTIGATORJessica D Richardson, PhD
University of New Mexico
Outcome results
None listed