Remotely-supervised Neuromodulation in PPA

University of Texas at Austin80 enrolled

Overview

The goal of this clinical trial is to learn whether remotely-supervised transcranial direct-current stimulation (RS-tDCS) can improve speech and language treatments for individuals with logopenic variant primary progressive aphasia (lvPPA). tDCS is a form of brain stimulation where a low-level electrical current is delivered to the brain through electrodes placed on the head. The main questions the trial aims to answer are: * Is it feasible to do RS-tDCS with virtual speech therapy? * How can brain magnetic resonance imaging scans (MRIs) predict how well someone will benefit from RS-tDCS with virtual speech therapy? Researchers will compare active RS-tDCS stimulation to sham stimulation (where there is no active stimulation, but participants feel stimulation effects at the beginning and end of the session). Participants will: * Travel to either the University of California, San Francisco (UCSF) or the University of Texas at Austin (UT Austin) one time for in-person testing, an MRI scan, and training on how to use the RS-tDCS equipment * Meet with a speech-language pathologist for pre-treatment testing on Zoom for 2 weeks * Participate in speech-language therapy and independent practice on Zoom 5 days a week for 4 weeks, using either active tDCS stimulation or sham * Complete post-treatment testing on Zoom for 1-2 weeks * Complete follow-up testing 2 months after completion of treatment

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Primary Progressive Aphasia(PPA)

Interventions

Lexical Retrieval Cascade TreatmentBEHAVIORAL

Participants work on producing spoken and written names of personally relevant target items using a self-cueing hierarchy. 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 StimulationDEVICE

tDCS is a type of non-invasive brain stimulation. 1.5 milliamp (mA) of current will be delivered via electrodes in saline-soaked sponges placed on the left and right sides of the head. During sham stimulation 1.5 milliamp (mA) of current will be delivered for a brief period and then turned off. The stimulation will be delivered for 20 minutes, 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.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Meets diagnostic criteria for primary progressive aphasia (PPA) * Meets diagnostic criteria for logopenic variant 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 teleconference meetings, as needed * Able and willing to undergo MRI brain scan * Access to high speed internet and basic experience using a computer and the internet * Individuals should be fluent speakers of English Exclusion Criteria: * Speech and language deficits better accounted for by another neurological disorder * Does not meet diagnostic criteria for logopenic variant 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

Outcomes

Primary Outcomes

Change in spoken naming

Change in percent correctly named trained/untrained pictures

Time frame: change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)

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.

Time frame: change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)

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.

Time frame: 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.

Time frame: one month after onset of treatment

Acceptability and Perception of Change Survey

The Acceptability and Perception of Change Survey characterizes perceived response to treatment.

Time frame: one month after onset of treatment

Remotely-supervised Neuromodulation in PPA

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts