Clinical trial NCT05901233: Speech-Language Treatment with Remotely Supervised Transcranial Direct Current Stimulation in Primary Progressive Aphasia
Official title: Telerehabilitation with Remotely-Supervised TDCS in Progressive Aphasia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Primary Progressive Aphasia
Keywords: Speech-Language Pathology
Primary Progressive Aphasia
Fronto-Temporal Dementia
Alzheimer's Disease
Neurodegenerative Disease
Logopenic
Semantic
Nonfluent
Logopenic Variant Primary Progressive Aphasia
Semantic Variant Primary Progressive Aphasia
Nonfluent Variant Primary Progressive Aphasia
Semantic Dementia
Speech Entrainment
Script Training
Teletherapy
Transcranial Direct Current Stimulation
Remotely-Supervised Transcranial Direct Current Stimulation
Lexical Retrieval
Noninvasive Brain Stimulation
Telehealth
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2023-06-13
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants undergo 4 weeks of video-implemented script training (VISTA) or Lexical Retrieval Training (LRT) with either sham or tDCS, a 2-month washout phase, and then another 4 weeks of LRT or VISTA with the other condition (sham or tDCS). Order will be randomized.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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, 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

Primary outcomes:
measure: 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)
measure: 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)
Secondary outcomes:
measure: Change on Communication Confidence Rating Scale for Aphasia
timeFrame: change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)
measure: Change on Aphasia Impact Questionnaire
timeFrame: change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)
measure: Client Satisfaction Questionnaire
timeFrame: four months after treatment onset
measure: Remotely-supervised Transcranial Direct Current Stimulation (RS-tDCS) Survey
timeFrame: four months after onset of treatment
measure: Care Partner Survey
timeFrame: four months after onset of treatment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Memory and Aging Center, University of California, San Francisco
state: California
city: Austin
country: United States
facility: University of Texas
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Maya Henry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.