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

Primary Progressive Aphasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05368350
• Other study ID #: UTD IRB: 20-71
• Status: Enrolling by invitation
• Phase: Early Phase 1
• Start date: June 1, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: The University of Texas at Dallas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) 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.

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 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 one open-label group 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Primary Progressive
• Apraxia of Speech
• Apraxias
• Frontotemporal Dementia
• Pick Disease of the Brain
• Primary Progressive Aphasia

Intervention

Device:
• Transcranial direct current stimulation
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 anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 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.

Locations

Country	Name	City	State
United States	The University of Texas at Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas at Dallas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.	Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
Secondary	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.	Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
Secondary	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.	Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
Secondary	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.	Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
Secondary	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.	Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.