Treating Primary Progressive Aphasia and Apraxia of Speech Using Non-invasive Brain Stimulation

May 6, 2026 updated by: John Hart, Jr., The University of Texas at Dallas

Treating Primary Progressive Aphasia and Apraxia of Speech With High Definition Transcranial Direct Current Stimulation (HDtDCS-PPA/PAOS)

The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., pre-supplementary motor area and left inferior frontal gyrus) thought to aid in memory will improve speech and language difficulties in patients with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS). The primary outcome measures are neuropsychological assessments of speech and language functions, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This pilot study has one treatment arm with open-label treatment and will examine improvement of speech output, verbal fluency, and other cognitive deficits associated with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS), by utilizing 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to pre-supplementary motor area or left inferior frontal gyrus for 20 minutes over 10 sessions. There will be baseline testing, and follow up testing immediately after and 8 weeks after completion of treatment.

All patients with a clinical diagnosis of PPA or PAOS will be assigned to either one of the two open-label arms to receive active tDCS. Primary outcome speech and language measures, secondary neuropsychological and electroencephalography (EEG) measures, and pre-screening assessments for study medical history and contraindications for treatment will be collected prior to the treatment (i.e., baseline).

Primary outcome speech and language functions measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected after treatment session 10 and following treatment competition (i.e., 8-week).

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • The University of Texas at Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 to 85 years of age
  • A formal diagnosis of primary progressive aphasia (nonfluent/agrammatic, semantic, logopenic variants or mixed) and/or progressive apraxia of speech
  • Capable of understanding and signing an informed consent. Medical information/history, as well as mental status exam and diagnosis provided by referring physician will determine whether or not a caregiver is required to be involved during this process.

Exclusion Criteria:

  • Has an implanted device, such as a pacemaker, metallic cranial implant, or a neurostimulator
  • Skull defects
  • Pregnant
  • A significant history of arrhythmia or epileptic seizures.
  • Not a native English speaker
  • Currently receiving speech-language intervention
  • Unable to communicated verbally

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Pre-SMA tDCS treatment
This open-label treatment will examine improvement of speech output, verbal fluency, and other cognitive deficits associated with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS), by utilizing 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to pre-supplementary motor area for 20 minutes over 10 sessions. There will be baseline testing, and follow up testing immediately after and 8 weeks after completion of treatment.
Device: high-definition transcranial direct current stimulation (HD-tDCS)

Other Names:

tDCS

1 milliamp tDCS High definition tDCS High definition transcranial direct current stimulator, Neuroelectrics Starstim tES, SN E20200930-10 Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with (1) Pre-SMA stimulation arm -- anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns or (2) LIFG stimulation arm -- at electrode F7 (International 10/10 System for electroencephalography electrode placement) and electrodes T7, FP1, AF3, and FC5 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds.
Experimental: Active LIFG tDCS treatment
This open-label treatment will examine improvement of speech output, verbal fluency, and other cognitive deficits associated with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS), by utilizing 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to left inferior frontal gyrus for 20 minutes over 10 sessions. There will be baseline testing, and follow up testing immediately after and 8 weeks after completion of treatment.
Device: high-definition transcranial direct current stimulation (HD-tDCS)

Other Names:

tDCS

1 milliamp tDCS High definition tDCS High definition transcranial direct current stimulator, Neuroelectrics Starstim tES, SN E20200930-10 Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with (1) Pre-SMA stimulation arm -- anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns or (2) LIFG stimulation arm -- at electrode F7 (International 10/10 System for electroencephalography electrode placement) and electrodes T7, FP1, AF3, and FC5 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Controlled Oral Word Association Test
Time Frame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

Evaluation of treatment differences in change on the Control Word Association Test

Benton, L.A., Hamsher, K., & Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.
Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
Category Fluency
Time Frame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

Evaluation of treatment differences in change on Category Fluency

Benton, L.A., Hamsher, K., & Sivan, A.B., (1994). Multilingual aphasia examination. Iowa City: AJA Associates.
Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
The Boston Naming Test
Time Frame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

Evaluation of treatment differences in change on The Boston Naming Test (accuracy and speech latency)

Kaplan, E., Goodglass, H., & Weintraub, S., (1983). Boston Naming Test (2nd ed.). Lea & Febiger: Philadelphia.
Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
Spontaneous speech (content and fluency) of the Western Aphasia Battery-Revised
Time Frame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

Evaluation of treatment differences in change on Spontaneous speech (content and fluency) of the Western Aphasia Battery-Revised

Kertesz, Andrew. ( 1982). The Western aphasia battery. New York :Grune & Stratton.
Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
The Apraxia battery for Adults - 2 (ABA - 2)
Time Frame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

Evaluation of treatment differences in change on characteristics of articulation of the the Apraxia battery for Adults - 2

Dabul, B. L. (2000). Apraxia Battery for Adults (ABA-2) (2nd edn). Austin, TX: ProEd.
Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Trail Making Test (Part A & B)
Time Frame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

Evaluation of treatment differences in change on The Trail Making Test (Part A & B)

Reitan, R.M., (1958). Validity of the Trail Making Test as an indicator of organic brain damage. Percept. Motor Skill., 8, 271-276.
Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
The Digit Span Forward & Backward
Time Frame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

Evaluation of treatment differences in change on The Digit Span Forward & Backward

Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
The Digit Symbol Substitution Test
Time Frame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

Evaluation of treatment differences in change on The Digit Symbol Substitution Test

Wechsler, D., (2008). Wechsler adult intelligence scale-Fourth Edition (WAIS-IV). San Antonio, TX: NCS Pearson.
Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
The Hopkins Verbal Learning Test-Revised
Time Frame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

Evaluation of treatment differences in change on The Hopkins Verbal Learning Test-Revised

Benedict, R. H. B., Schretlen, D., Groninger, L., & Brandt, J. (1998). The Hopkins verbal learning test-revised: Normative data and analysis of interform and test-retest reliability. Clinical Neuropsychologist, 12, 43-55.
Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
The Rey-Osterrieth Complex Figure Test
Time Frame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

Evaluation of treatment differences in change on The Rey-Osterrieth Complex Figure Test

Rey, A. (1941). L'examen psychologique dans les cas d'encéphalopathie traumatique. (Les problems.). [The psychological examination in cases of traumatic encepholopathy. Problems.]. Archives de Psychologie, 28, 215- 285.
Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas at Dallas

Investigators

  • Principal Investigator: John Hart, MD, The University of Texas at Dallas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

April 16, 2027

Study Completion (Estimated)

April 16, 2027

Study Registration Dates

First Submitted

May 5, 2022

First Submitted That Met QC Criteria

May 5, 2022

First Posted (Actual)

May 10, 2022

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTD IRB: 24-595

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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