About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Lexical Retrieval Cascade Treatment
BehavioralParticipants 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.
Remotely Supervised Transcranial Direct Current Stimulation- Active
DevicetDCS 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.
Remotely Supervised Transcranial Direct Current Stimulation - Sham
DevicetDCS 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in spoken naming
Change in percent correctly named trained/untrained pictures
Secondary outcomes
Change on Communication Confidence Rating Scale for Aphasia
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 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
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
The Acceptability and Perception of Change Survey characterizes perceived response to treatment.
Sponsors and contacts
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Maya Henry
Lead sponsor
University of Texas at Austin
Sponsor institution
National Institute on Aging (NIA)
Collaborator