Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05368350

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Primary Progressive Aphasia Aphasia Aphasia, Primary Progressive Apraxia of Speech Apraxias Brain Diseases Central Nervous System Diseases Communication Disorders Dementia Language Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Disorders Signs and Symptoms Speech Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas at Dallas

Dallas, Texas, 75235, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

The University of Texas at Dallas

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 10, 2022
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.