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Active, not recruitingNCT05368350Updated May 8, 2026

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

An interventional study of high-definition transcranial direct current stimulation (HD-tDCS) in Primary Progressive Aphasia and Apraxia of Speech, sponsored by The University of Texas at Dallas. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by The University of Texas at Dallas · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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.

Read the 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).

02

Conditions studied

  • Primary Progressive Aphasia
  • Apraxia of Speech
03

In context

Aphasia, Primary Progressive

77 studies on the registry are indexed under Aphasia, Primary Progressive; 29 are open to participants now.

This study's enrollment of 12 is below the median of 30 across 60 interventional studies indexed under Aphasia, Primary Progressive.

Browse Aphasia, Primary Progressive studies →

Lead sponsor

The University of Texas at Dallas is the lead sponsor of 60 studies on the registry; 19 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 . 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • 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)

  • 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)

Interventions

  • Devicehigh-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.

06

What researchers measure

Primary outcomes

  1. The Controlled Oral Word Association Test

    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.

    Time frame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

  2. Category Fluency

    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.

    Time frame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

  3. The Boston Naming Test

    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.

    Time frame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

  4. Spontaneous speech (content and fluency) of the Western Aphasia Battery-Revised

    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.

    Time frame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

  5. The Apraxia battery for Adults - 2 (ABA - 2)

    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.

    Time frame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

Secondary outcomes

  1. The Trail Making Test (Part A & B)

    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.

    Time frame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

  2. The Digit Span Forward & Backward

    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.

    Time frame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

  3. The Digit Symbol Substitution Test

    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.

    Time frame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

  4. The Hopkins Verbal Learning Test-Revised

    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.

    Time frame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

  5. The Rey-Osterrieth Complex Figure Test

    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.

    Time frame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

07

Study locations

1 site
08

References and documents

Publications

  • Dugas CS, Chiang HS, Devora P, Lucas-Mendoza K, Abasi C, Adhikari A, Nguyen T, Frolov A, Kelley BJ, LoBue C, Mudar RA, Hart J Jr. High-definition brain stimulation targeting separate regions leads to differential word retrieval outcomes in patients with primary progressive aphasia: a pilot study. Front Neurol. 2025 Sep 17;16:1630103. doi: 10.3389/fneur.2025.1630103. eCollection 2025. PubMed 41041680 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2022 (actual). Primary completion is estimated for Apr 2027, 58 months after the start.

Of 38 non-industry interventional studies with no phase under Aphasia, Primary Progressive, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 59. This study's planned 58 months is above that.

Counting every sponsor, half of 38 studies reached it within 41 months; a quarter within 26 and three quarters within 59.

How these figures are worked out, and which studies are left out of them.

Registered
May 5, 2022
First posted
May 10, 2022
StartActual
Jun 1, 2022
Primary completionEst.
Apr 16, 2027
CompletionEst.
Apr 16, 2027
Last update
May 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05368350
Lead sponsor
The University of Texas at Dallas
Responsible party
John Hart, Jr. (Professor, The University of Texas at Dallas) — Principal investigator
First posted
May 10, 2022
Start date
Jun 1, 2022
Primary completion
Apr 16, 2027 (estimated)
Completion
Apr 16, 2027 (estimated)
Last update
May 8, 2026

Study contacts

John Hart, MD
principal investigator · The University of Texas at Dallas

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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