Remotely-supervised Neuromodulation in PPA

The University of Texas System (UT)

Status: Enrolling

Conditions: Logopenic Variant Primary Progressive Aphasia; Progressive Aphasia; Progressive Aphasia in Alzheimer's Disease; Logopenic Progressive Aphasia (LPA); Primary Progressive Aphasia(PPA); Logopenic Variant of Primary Progressive Aphasia (LPA)

Treatments: Device: Remotely Supervised Transcranial Direct Current Stimulation; Behavioral: Lexical Retrieval Cascade Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07260253

RF1AG085565 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Language Therapy with Active Stimulation

Experimental group

Description:

Transcranial direct current stimulation (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. The stimulation will be delivered for 20 minutes, 5 times weekly, in the participant's home setting while the participant engages in virtual speech-language training. Sessions are monitored by study personnel.

Treatment:

Behavioral: Lexical Retrieval Cascade Treatment

Device: Remotely Supervised Transcranial Direct Current Stimulation

Language Therapy with Sham Stimulation

Sham Comparator group

Description:

Transcranial direct current stimulation (tDCS) is a type of non-invasive brain stimulation. During sham stimulation 1.5 milliamp (mA) of current will be delivered for a brief period and then turned off. Current will be delivered via electrodes in saline-soaked sponges placed on the left and right sides of the head. Sham will be delivered for 20 minutes, 5 times weekly, in the participant's home setting while the participant engages in virtual speech-language training. Sessions are monitored by study personnel.

Treatment:

Behavioral: Lexical Retrieval Cascade Treatment

Device: Remotely Supervised Transcranial Direct Current Stimulation