Clinical trial NCT05368350: Treating Primary Progressive Aphasia and Apraxia of Speech Using Non-invasive Brain Stimulation
Official title: Treating Primary Progressive Aphasia and Apraxia of Speech With High Definition Transcranial Direct Current Stimulation (HDtDCS-PPA/PAOS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Primary Progressive Aphasia
Apraxia of Speech
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: The Controlled Oral Word Association Test
timeFrame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
measure: Category Fluency
timeFrame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
measure: The Boston Naming Test
timeFrame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
measure: Spontaneous speech (content and fluency) of the Western Aphasia Battery-Revised
timeFrame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
measure: The Apraxia battery for Adults - 2 (ABA - 2)
timeFrame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
Secondary outcomes:
measure: The Trail Making Test (Part A & B)
timeFrame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
measure: The Digit Span Forward & Backward
timeFrame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
measure: The Digit Symbol Substitution Test
timeFrame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
measure: The Hopkins Verbal Learning Test-Revised
timeFrame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
measure: The Rey-Osterrieth Complex Figure Test
timeFrame: Treatment change from Baseline to Immediate post, and 8 weeks post treatment completion.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The University of Texas at Dallas
state: Texas
Study officials:
affiliation: University of Texas at Dallas
name: John Hart, MD
role: PRINCIPAL_INVESTIGATOR
References: