Clinical trial NCT02622945: Effects of Transcranial Direct Current Stimulation in Post-stroke Aphasia
Official title: Transcranial Direct Current Stimulation in Acute and Chronic Post-stroke Aphasia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Aphasia
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2015-12-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to determine whether transcranial direct current stimulation (tDCS) paired with speech-language therapy is more beneficial than speech-language therapy alone in acute and chronic post-stroke aphasia.

Detailed description: This study aims to determine whether behavioral word-retrieval therapy coupled with anodal tDCS will improve the fluency and name retrieval performance of participants with post-stroke aphasia more efficiently and for greater duration than language therapy alone (i.e. in the sham condition).

tDCS neuronal targets will be selected in this order:

1. left posterior superior-middle temporal gyrus (an area critical for word retrieval and word comprehension),
2. left posterior frontal areas found to be responsible for lexical selection if the first area is infarcted, or
3. right cerebellum (important for learning, and consistently activated in naming task) if both of the other areas are infarcted.

The same areas will be stimulated during the first tDCS and sham periods. If the participant returns for a second period of tDCS and sham with language therapy, the right cerebellum will be stimulated (if it was the only uninfarcted target area investigators will stimulate this area again). For cerebellar stimulation, either anodal or cathodal will be used as studies show that anodal or cathodal stimulation has an effect on cognitive functions.

Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed with with post-stroke aphasia and word-retrieval deficits
* Premorbid speakers of English
* Diagnosis will be based on neuropsychological testing, language testing (most commonly the Western Aphasia Battery), MRI and clinical assessment
* Stroke size: any l
* Location: Left hemisphere strokes only from any etiology.
* Time since stroke onset: 1 day to 20 years.

Exclusion Criteria:

* uncorrected visual or hearing impairment by self report
* other premorbid neurological disorder affecting the brain
* any other language-based learning disorder or other neurodegenerative disorder such as Alzheimer's Disease or Primary Progressive Aphasia
* premorbidly diagnosed with a developmental language disorder
* Pregnant women will also be excluded

Primary outcomes:
measure: Change in picture naming scores in trained and untrained items
timeFrame: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups
Secondary outcomes:
measure: Change in Philadelphia Naming Test: Picture naming of everyday objects, different from training set
timeFrame: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups
measure: Change in Written naming of objects and actions
timeFrame: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups
measure: Change in working memory (digit span)
timeFrame: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups
measure: Change in verbal fluency
timeFrame: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medicine
state: Maryland
Study officials:
References:
citation: Schlaug G, Marchina S, Wan CY. The use of non-invasive brain stimulation techniques to facilitate recovery from post-stroke aphasia. Neuropsychol Rev. 2011 Sep;21(3):288-301. doi: 10.1007/s11065-011-9181-y. Epub 2011 Aug 14.
citation: Dmochowski JP, Datta A, Huang Y, Richardson JD, Bikson M, Fridriksson J, Parra LC. Targeted transcranial direct current stimulation for rehabilitation after stroke. Neuroimage. 2013 Jul 15;75:12-19. doi: 10.1016/j.neuroimage.2013.02.049. Epub 2013 Mar 5.