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

NCT05368350 | Active Not Recruiting FDA Device

• 1 other identifier: UTD IRB: 24-595
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Progressive Aphasia; Apraxia of Speech

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

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

Secondary Outcomes (5)

• The Trail Making Test (Part A & B)

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

• The Digit Span Forward & Backward

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

• The Digit Symbol Substitution Test

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

• The Hopkins Verbal Learning Test-Revised

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

• The Rey-Osterrieth Complex Figure Test

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

Study Arms (2)

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.

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.

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

Interventions

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.

Active LIFG tDCS treatment; Active Pre-SMA tDCS treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas at Dallas: lead

Study Sites (1)

The University of Texas at Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• 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.

  PMID: 41041680 DERIVED

MeSH Terms

Conditions

Aphasia, Primary Progressive; Apraxias

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Psychomotor Disorders

Study Officials

• John Hart, MD

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Study participants will be assigned to either Pre-SMA or LIFG arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 10, 2022
• Study Start: June 1, 2022
• Primary Completion: April 16, 2026
• Study Completion: April 16, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04

Locations

US (1)