search
Back to results

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

Primary Purpose

Primary Progressive Aphasia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remotely supervised Transcranial Direct Current Stimulation (RS-tDCS)
Remotely supervised sham tDCS (RS-sham-tDCS)
Lexical Retrieval Training (LRT)
Video Implemented Script Training in Aphasia (VISTA)
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Progressive Aphasia focused on measuring Speech-Language Pathology, Primary Progressive Aphasia, Fronto-Temporal Dementia, Alzheimer's Disease, Neurodegenerative Disease, Logopenic, Semantic, Nonfluent, Logopenic Variant Primary Progressive Aphasia, Semantic Variant Primary Progressive Aphasia, Nonfluent Variant Primary Progressive Aphasia, Semantic Dementia, Speech Entrainment, Script Training, Teletherapy, Transcranial Direct Current Stimulation, Remotely-Supervised Transcranial Direct Current Stimulation, Lexical Retrieval, Noninvasive Brain Stimulation, Telehealth

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Because PPA is a rare disease, the study aims to recruit all eligible participants with PPA who are referred to the Aphasia Research and Treatment Lab at the University of Texas (UT) Austin, the UT/Dell Medical School Department of Neurology, and the University of California at San Francisco (UCSF) Memory and Aging Center, as well as individuals with PPA from other clinical and research sites. The study will aim to include males, females, and transgender or non-binary individuals. Great efforts will be made to recruit participants from minority populations, subject to the limitation that participants need to be fluent speakers of English. 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

Sites / Locations

  • Memory and Aging Center, University of California, San Francisco
  • University of Texas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

RS-LRT

RS-VISTA

Arm Description

Outcomes

Primary Outcome Measures

RS-LRT arm: Change in spoken naming
Change in percent correctly named trained/untrained pictures
RS-VISTA arm: Change in script production accuracy
Change in percent correct, intelligible, scripted words produced for trained/untrained scripts

Secondary Outcome Measures

Change on Communication Confidence Rating Scale for Aphasia
Change on 10-item Likert-type self-rating scale evaluating communication confidence in different settings for persons with aphasia. A higher score indicates greater confidence.
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.
Client Satisfaction Questionnaire
Likert-type scale measuring patient/client satisfaction with intervention. A higher score indicates greater satisfaction.
Remotely-supervised Transcranial Direct Current Stimulation (RS-tDCS) Survey
Likert type scale used to capture participants' perceptions regarding the acceptability and potential demand for remotely-supervised tDCS.
Care Partner Survey
Likert-type scale used to characterize care partners' perceptions of the benefits of speech-language treatment.

Full Information

First Posted
May 8, 2023
Last Updated
July 25, 2023
Sponsor
University of Texas at Austin
Collaborators
University of California, San Francisco
search

1. Study Identification

Unique Protocol Identification Number
NCT05901233
Brief Title
Speech-Language Treatment With Remotely Supervised Transcranial Direct Current Stimulation in Primary Progressive Aphasia
Official Title
Telerehabilitation With Remotely-Supervised tDCS in Progressive Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
Collaborators
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Progressive Aphasia
Keywords
Speech-Language Pathology, Primary Progressive Aphasia, Fronto-Temporal Dementia, Alzheimer's Disease, Neurodegenerative Disease, Logopenic, Semantic, Nonfluent, Logopenic Variant Primary Progressive Aphasia, Semantic Variant Primary Progressive Aphasia, Nonfluent Variant Primary Progressive Aphasia, Semantic Dementia, Speech Entrainment, Script Training, Teletherapy, Transcranial Direct Current Stimulation, Remotely-Supervised Transcranial Direct Current Stimulation, Lexical Retrieval, Noninvasive Brain Stimulation, Telehealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The order of administration for active and sham stimulation phases will be masked for the participant, study partner, study clinician, and primary investigator.
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RS-LRT
Arm Type
Experimental
Arm Title
RS-VISTA
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Remotely supervised Transcranial Direct Current Stimulation (RS-tDCS)
Intervention Description
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
Intervention Name(s)
Remotely supervised sham tDCS (RS-sham-tDCS)
Intervention Description
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
Behavioral
Intervention Name(s)
Lexical Retrieval Training (LRT)
Intervention Description
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
Intervention Name(s)
Video Implemented Script Training in Aphasia (VISTA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
RS-LRT arm: Change in spoken naming
Description
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)
Title
RS-VISTA arm: Change in script production accuracy
Description
Change in percent correct, intelligible, scripted words produced for trained/untrained scripts
Time Frame
change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)
Secondary Outcome Measure Information:
Title
Change on Communication Confidence Rating Scale for Aphasia
Description
Change on 10-item Likert-type self-rating scale evaluating communication confidence in different settings for persons with aphasia. A higher score indicates greater confidence.
Time Frame
change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)
Title
Change on Aphasia Impact Questionnaire
Description
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.
Time Frame
change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)
Title
Client Satisfaction Questionnaire
Description
Likert-type scale measuring patient/client satisfaction with intervention. A higher score indicates greater satisfaction.
Time Frame
four months after treatment onset
Title
Remotely-supervised Transcranial Direct Current Stimulation (RS-tDCS) Survey
Description
Likert type scale used to capture participants' perceptions regarding the acceptability and potential demand for remotely-supervised tDCS.
Time Frame
four months after onset of treatment
Title
Care Partner Survey
Description
Likert-type scale used to characterize care partners' perceptions of the benefits of speech-language treatment.
Time Frame
four months after onset of treatment

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Because PPA is a rare disease, the study aims to recruit all eligible participants with PPA who are referred to the Aphasia Research and Treatment Lab at the University of Texas (UT) Austin, the UT/Dell Medical School Department of Neurology, and the University of California at San Francisco (UCSF) Memory and Aging Center, as well as individuals with PPA from other clinical and research sites. The study will aim to include males, females, and transgender or non-binary individuals. Great efforts will be made to recruit participants from minority populations, subject to the limitation that participants need to be fluent speakers of English. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maya Henry, PhD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memory and Aging Center, University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
University of Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29718131
Citation
Henry ML, Hubbard HI, Grasso SM, Mandelli ML, Wilson SM, Sathishkumar MT, Fridriksson J, Daigle W, Boxer AL, Miller BL, Gorno-Tempini ML. Retraining speech production and fluency in non-fluent/agrammatic primary progressive aphasia. Brain. 2018 Jun 1;141(6):1799-1814. doi: 10.1093/brain/awy101. Erratum In: Brain. 2018 Jul 1;141(7):e57.
Results Reference
background
PubMed Identifier
31390290
Citation
Henry ML, Hubbard HI, Grasso SM, Dial HR, Beeson PM, Miller BL, Gorno-Tempini ML. Treatment for Word Retrieval in Semantic and Logopenic Variants of Primary Progressive Aphasia: Immediate and Long-Term Outcomes. J Speech Lang Hear Res. 2019 Aug 15;62(8):2723-2749. doi: 10.1044/2018_JSLHR-L-18-0144. Epub 2019 Aug 7.
Results Reference
background
PubMed Identifier
30880927
Citation
Dial HR, Hinshelwood HA, Grasso SM, Hubbard HI, Gorno-Tempini ML, Henry ML. Investigating the utility of teletherapy in individuals with primary progressive aphasia. Clin Interv Aging. 2019 Feb 25;14:453-471. doi: 10.2147/CIA.S178878. eCollection 2019.
Results Reference
background
Links:
URL
https://slhs.utexas.edu/research/aphasia-research-treatment-lab
Description
University of Texas Aphasia Research and Treatment Lab
URL
https://albalab.ucsf.edu
Description
UCSF Language Neurobiology Lab

Learn more about this trial

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

We'll reach out to this number within 24 hrs