Clinical trial NCT02540109: Targeted Electrotherapy for Aphasia Stroke Rehabilitation (TEASER) - Phase II Multi-Center Study
Official title: Targeted Transcranial Electrotherapy for Stroke Rehabilitation - Exploratory Trial on Aphasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Aphasia
Keywords: Stroke
Anomia
Lead sponsor: Soterix Medical
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Georgetown University
name: University of North Carolina, Chapel Hill
name: The City College of New York
name: Medstar Health Research Institute
name: University of South Carolina
First posted: 2015-09-03
Enrollment: 58
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase II study aims to ascertain the effectiveness of HD-tDCS for adjunctive treatment of anomia in chronic aphasia post stroke. Furthermore, it will help explore factors such as alternate outcome measures, subject selection criteria, and benefits of extended treatment duration. These results will be compared to an existing trial using conventional non-targeted tDCS with the same design and outcomes. Patients will be treated with HD-tDCS while performing computerized anomia treatment. The basis behind this method is that language therapy is mediated by cortical areas that are most effectively activated during the training tasks, thus increasing electric stimulation in these areas may improve learning outcomes. To better understand the long term benefits of the adjunctive treatment, patients will be screened again four weeks and six months after study using the same anomia tests. If HD-tDCS shows promising results in increasing the learning outcomes of anomia treatment, a Phase III trial can be considered.


Eligibility criteria: Inclusion Criteria:

* one-time ischemic stroke in the left hemisphere
* greater than 6-months post-stroke onset
* between 25 and 75 years of age
* aphasia diagnosis (as determined by pre-treatment language-based testing)
* right-handed (before the stroke)
* native speaker of English
* ability to provide informed written or verbal consent

Exclusion Criteria:

* clinically reported history of dementia, alcohol abuse, psychiatric disorder, traumatic brain injury, or extensive visual acuity or visual-spatial problems
* factors contraindicative of tDCS administration (sensitive scalp, previous brain surgery)
* prior history of epileptic or unprovoked seizures occurring during the previous 12 months.
* Presence of Metal implants of claustrophobia (not able to undergo MRI)
* Pregnancy
* Presence of any other neurological disease than stroke
* Childhood history of speech, language, hearing, or intellectual impairment

Primary outcomes:
measure: Effect size of HD-tDCS for the adjunctive treatment of anomia in chronic aphasia after stroke
timeFrame: 3 weeks
Secondary outcomes:
measure: Determine alternate outcome measures
timeFrame: 4 weeks and 6 months follow up
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Medical Center (Peter Turkeltaub, MD, Ph.D.)
state: District of Columbia
city: Chapel Hill
country: United States
facility: University of North Carolina School of Medicine (Adam Jacks, Ph.D.)
state: North Carolina
Study officials:
affiliation: Soterix Medical Inc.
name: Abhishek Datta, Ph.D
role: STUDY_CHAIR
affiliation: City University of New York - CCNY
name: Lucas C Parra, Ph.D
role: STUDY_CHAIR
References: