Primary Progressive AphasiaNCT05368350

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

A study testing high-definition transcranial direct current stimulation (HD-tDCS) in people with Primary Progressive Aphasia and Apraxia of Speech, run by The University of Texas at Dallas at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Primary Progressive Aphasia, Apraxia of Speech
What is being tested?: high-definition transcranial direct current stimulation (HD-tDCS)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2022to 16 Apr 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas at Dallas
Dallas, Texas, 75235

Other trials in United States

About this study

Official title: 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.

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).

Conditions: Primary Progressive Aphasia, Apraxia of Speech
Being tested: high-definition transcranial direct current stimulation (HD-tDCS)
Medical subject headings: Aphasia, Primary Progressive, Apraxias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

high-definition transcranial direct current stimulation (HD-tDCS)Device
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.

Study groups in NCT05368350
Study group	Role	What they receive
Active Pre-SMA tDCS treatment	Experimental	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. Receives: Device: high-definition transcranial direct current stimulation (HD-tDCS)
Active LIFG tDCS treatment	Experimental	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. Receives: Device: high-definition transcranial direct current stimulation (HD-tDCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202216 Apr 2027

First posted10 May 2022
Study start1 Jun 2022
Primary completion16 Apr 2027 (estimated)
Study completion16 Apr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Primary Progressive AphasiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05368350
Sponsor's protocol ID: UTD IRB: 24-595
Status last verified: May 2026
First submitted: 5 May 2022
Last updated: 8 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Primary Progressive Aphasia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treating Primary Progressive Aphasia and Apraxia of Speech With High Definition Transcranial Direct Current Stimulation (HDtDCS-PPA/PAOS)
ClinicalTrials.gov ID: NCT05368350
Acronym / sponsor ID: UTD IRB: 24-595
Conditions: Primary Progressive Aphasia, Apraxia of Speech
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 12 participants (actual)
Lead sponsor: The University of Texas at DallasUniversity, hospital or other
Study start: 1 Jun 2022 (actual)
Primary completion: 16 Apr 2027 (estimated)
Study completion: 16 Apr 2027 (estimated)
First posted: 10 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Active Pre-SMA tDCS treatment	Experimental	Device: high-definition transcranial direct current stimulation (HD-tDCS)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.
Active LIFG tDCS treatment	Experimental	Device: high-definition transcranial direct current stimulation (HD-tDCS)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.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Active LIFG tDCS treatment, Active Pre-SMA tDCS treatment

Primary outcome

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.
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.
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.
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.
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.

5 secondary outcomes

The Trail Making Test (Part A & B)
Time frame: 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.
The Digit Symbol Substitution Test
Time frame: 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.
The Rey-Osterrieth Complex Figure Test
Time frame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
Derived from this study: PubMed 41041680Dugas 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Hart, MD principal investigator

The University of Texas at Dallas

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Controlled Oral Word Association Test (time frame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05368350, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.