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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Primary Progressive Aphasia, Apraxia of Speech

Intervention / Treatment
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* Device: Transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tDCS treatment<br>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. | Device: Transcranial direct current stimulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. |