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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-10

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Progressive Aphasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Participants undergo 4 weeks of video-implemented script training (VISTA) or Lexical Retrieval Training (LRT) with either sham or tDCS, a 2-month washout phase, and then another 4 weeks of LRT or VISTA with the other condition (sham or tDCS). Order will be randomized.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The order of administration for active and sham stimulation phases will be masked for the participant, study partner, study clinician, and primary investigator.

Study Groups

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RS-LRT

Group Type EXPERIMENTAL

Remotely supervised Transcranial Direct Current Stimulation (RS-tDCS)

Intervention Type DEVICE

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 side of the head and right upper arm. 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.

Remotely supervised sham tDCS (RS-sham-tDCS)

Intervention Type DEVICE

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 side of the head and right upper arm. Sham 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.

Lexical Retrieval Training (LRT)

Intervention Type BEHAVIORAL

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.

RS-VISTA

Group Type EXPERIMENTAL

Remotely supervised Transcranial Direct Current Stimulation (RS-tDCS)

Intervention Type DEVICE

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 side of the head and right upper arm. 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.

Remotely supervised sham tDCS (RS-sham-tDCS)

Intervention Type DEVICE

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 side of the head and right upper arm. Sham 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.

Video Implemented Script Training in Aphasia (VISTA)

Intervention Type BEHAVIORAL

Participants work on producing personally relevant scripts of 4-6 sentences in length. Length and complexity of scripts are individually tailored. The participant completes two (one hour each) teletherapy sessions per week with a clinician targeting clear and accurate script production, script memorization, and conversational usage of scripts. The participant completes 30 minutes of independent, computer-based practice 3 times per week, during which they speak in unison with a video/audio model of a healthy speaker clearly articulating the scripts.

Interventions

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Remotely supervised Transcranial Direct Current Stimulation (RS-tDCS)

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 side of the head and right upper arm. 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.

Intervention Type DEVICE

Remotely supervised sham tDCS (RS-sham-tDCS)

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 side of the head and right upper arm. Sham 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.

Intervention Type DEVICE

Lexical Retrieval Training (LRT)

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.

Intervention Type BEHAVIORAL

Video Implemented Script Training in Aphasia (VISTA)

Participants work on producing personally relevant scripts of 4-6 sentences in length. Length and complexity of scripts are individually tailored. The participant completes two (one hour each) teletherapy sessions per week with a clinician targeting clear and accurate script production, script memorization, and conversational usage of scripts. The participant completes 30 minutes of independent, computer-based practice 3 times per week, during which they speak in unison with a video/audio model of a healthy speaker clearly articulating the scripts.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes