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| ID | Type | Description | Link |
|---|---|---|---|
| RF1AG085565 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Language Therapy with Active Stimulation | Experimental | Participants will receive virtual language therapy in conjunction with active remotely-supervised transcranial direct current stimulation. |
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| Language Therapy with Sham Stimulation | Sham Comparator | Participants will receive virtual language therapy in conjunction with sham remotely-supervised transcranial direct current stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lexical Retrieval Cascade Treatment | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in spoken naming | Change in percent correctly named trained/untrained pictures | change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aphasia Lab Research Coordinator | Contact | 512-471-3420 | aphasialab@austin.utexas.edu |
| Name | Affiliation | Role |
|---|---|---|
| Maya L Henry, PhD | University of Texas at Austin | Principal Investigator |
| Jessica D Richardson, PhD | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Memory and Aging Cener | Recruiting | San Francisco | California | 94158 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30880927 | Background | 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. | |
| 31390290 | Background | 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. |
| Label | URL |
|---|---|
| University of Texas Aphasia Research and Treatment Lab | View source |
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De-identified individual participant data, including behavioral and MRI/fMRI data from 80 individuals with lvPPA and limited data from study partners, will be shared via the ICPSR repository. Data will be available at publication or within 9 months of database lock, and accessible for at least 10 years. Publicly shared datasets will exclude identifiable information, audio/video files, and non-skull-stripped imaging. Additional data may be shared via IRB-approved data-sharing agreements.
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De-identified clinical trial data (participant level and summary level data, raw and processed) will be made available at the time of publication of the primary results or within 9 months of database lock, whichever comes first. We will also include relevant datasets as supplementary material accompanying articles submitted to PubMed Central. Data will be publicly available for 10 years following the end of the award and by request thereafter.
De-identified data will be accessible to researchers and the broader scientific community. Publicly available datasets will be hosted on the ICPSR repository and accessible via DOI. Additional data (e.g., voice samples) may be accessed through an IRB-approved data-sharing agreement, which will require users to commit to secure data handling and non-identification of participants.
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Participants will be randomized into one of two arms: sham or active remotely-supervised transcranial direct current stimulation (RS-tDCS).
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| Remotely Supervised Transcranial Direct Current Stimulation- Active | Device | 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. |
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| Remotely Supervised Transcranial Direct Current Stimulation - Sham | Device | 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. |
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| 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. | 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 | 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. | one month after onset of treatment |
| Acceptability and Perception of Change Survey | The Acceptability and Perception of Change Survey characterizes perceived response to treatment. | one month after onset of treatment |
| University of Texas | Recruiting | Austin | Texas | 78712 | United States |
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| ID | Term |
|---|---|
| D018888 | Aphasia, Primary Progressive |
| D001037 | Aphasia |
| D003147 | Communication Disorders |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D065886 | Neurodevelopmental Disorders |
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