Remotely-supervised Neuromodulation in PPA

Maya Henry80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Primary Progressive Aphasia(PPA)

Interventions

Lexical Retrieval Cascade TreatmentBEHAVIORAL

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.

Remotely Supervised Transcranial Direct Current Stimulation- ActiveDEVICE

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.

Remotely Supervised Transcranial Direct Current Stimulation - ShamDEVICE

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.

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 * Attains score of 20 or higher on the Mini-Mental State Examination * Has adequate hearing and vision (with hearing or vision aids, if needed) * Is able to travel to research site and undergo MRI brain scan * Has access to high speed internet and basic experience using a computer and the internet * Is a fluent speaker of English * Has a study partner who can co-enroll in the study, attend pre-treatment training at the research site, and be present for teleconference meetings, as needed Exclusion Criteria: * Speech and language deficits better accounted for by another neurological disorder * Does not meet diagnostic criteria for logopenic variant PPA * Scores less than 20 on the Mini-Mental State Examination * Does not have a study partner who can co-enroll in the study * Has 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) * Has a 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