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Speech-Language Treatment with Remotely Supervised Transcranial Direct Current Stimulation in Primary Progressive Aphasia

Not Applicable
Active, not recruiting
Conditions
Primary Progressive Aphasia
Interventions
Device: Remotely supervised Transcranial Direct Current Stimulation (RS-tDCS)
Device: Remotely supervised sham tDCS (RS-sham-tDCS)
Behavioral: Video Implemented Script Training in Aphasia (VISTA)
Behavioral: Lexical Retrieval Training (LRT)
Registration Number
NCT05901233
Lead Sponsor
University of Texas at Austin
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
10
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
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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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
RS-LRTRemotely supervised Transcranial Direct Current Stimulation (RS-tDCS)-
RS-VISTARemotely supervised sham tDCS (RS-sham-tDCS)-
RS-VISTAVideo Implemented Script Training in Aphasia (VISTA)-
RS-LRTRemotely supervised sham tDCS (RS-sham-tDCS)-
RS-VISTARemotely supervised Transcranial Direct Current Stimulation (RS-tDCS)-
RS-LRTLexical Retrieval Training (LRT)-
Primary Outcome Measures
NameTimeMethod
RS-LRT arm: Change in spoken namingchange 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

RS-VISTA arm: Change in script production accuracychange from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)

Change in percent correct, intelligible, scripted words produced for trained/untrained scripts

Secondary Outcome Measures
NameTimeMethod
Change on Communication Confidence Rating Scale for Aphasiachange from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)

Change on 10-item Likert-type self-rating scale evaluating communication confidence in different settings for persons with aphasia. A higher score indicates greater confidence.

Change on Aphasia Impact Questionnairechange 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.

Client Satisfaction Questionnairefour months after treatment onset

Likert-type scale measuring patient/client satisfaction with intervention. A higher score indicates greater satisfaction.

Remotely-supervised Transcranial Direct Current Stimulation (RS-tDCS) Surveyfour months after onset of treatment

Likert type scale used to capture participants' perceptions regarding the acceptability and potential demand for remotely-supervised tDCS.

Care Partner Surveyfour months after onset of treatment

Likert-type scale used to characterize care partners' perceptions of the benefits of speech-language treatment.

Trial Locations

Locations (2)

Memory and Aging Center, University of California, San Francisco

🇺🇸

San Francisco, California, United States

University of Texas

🇺🇸

Austin, Texas, United States

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