Treating Primary Progressive Aphasia and Apraxia of Speech Using Non-invasive Brain Stimulation
- Conditions
- Apraxia of SpeechPrimary Progressive Aphasia
- Interventions
- Device: Transcranial direct current stimulation
- Registration Number
- NCT05368350
- Lead Sponsor
- The University of Texas at Dallas
- 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.
- 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 12
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active tDCS treatment Transcranial direct current stimulation 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.
- Primary Outcome Measures
Name Time Method Category Fluency 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 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.The Controlled Oral Word Association Test 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.The Apraxia battery for Adults - 2 (ABA - 2) 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.Spontaneous speech (content and fluency) of the Western Aphasia Battery-Revised 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.
- Secondary Outcome Measures
Name Time Method The Trail Making Test (Part A & B) 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.The Rey-Osterrieth Complex Figure Test 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.The Digit Symbol Substitution Test 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.The Hopkins Verbal Learning Test-Revised 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.The Digit Span Forward & Backward 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.
Trial Locations
- Locations (1)
The University of Texas at Dallas
🇺🇸Dallas, Texas, United States