Remotely-supervised Neuromodulation in PPA

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorMaya Henry

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Meets diagnostic criteria for primary progressive aphasia (PPA)

Meets diagnostic criteria for logopenic variant PPA

Attains score of 15 or higher on the Mini-Mental State Examination

Has adequate hearing and vision (with hearing or vision aids, if needed)

Disqualifiers

Speech and language deficits better accounted for by another neurological disorder

Does not meet diagnostic criteria for logopenic variant PPA

Scores less than 15 on the Mini-Mental State Examination

Does not have a study partner who can co-enroll in the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Language Therapy with Active StimulationExperimental treatment 2 interventions
Group B: Language Therapy with Sham StimulationSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

1

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)
2

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)
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Maya Henry

Lead sponsor

University of Texas at Austin

Sponsor institution

National Institute on Aging (NIA)

Collaborator