Effects of Transcranial Direct Current Stimulation in Post-stroke Aphasia
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|ClinicalTrials.gov Identifier: NCT02622945|
Recruitment Status : Recruiting
First Posted : December 7, 2015
Last Update Posted : March 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Aphasia||Device: Active tDCS plus Speech-Language Therapy Device: Sham plus Speech-Language Therapy||Phase 2|
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:
- left posterior superior-middle temporal gyrus (an area critical for word retrieval and word comprehension),
- left posterior frontal areas found to be responsible for lexical selection if the first area is infarcted, or
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Transcranial Direct Current Stimulation in Acute and Chronic Post-stroke Aphasia|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Active tDCS plus Speech-Language Therapy
Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min. Language therapy will be oral and written naming. This is a cross-over study so all participants will receive this arm but the order will be randomized.
Device: Active tDCS plus Speech-Language Therapy
Stimulation will be delivered by a battery-driven constant current stimulator. The electrical current will be administered to a pre-specified region of the brain not affected by the lesion(perilesional areas, right hemisphere or cerebellum). The stimulation will be delivered at an intensity of 2mA (estimated current density 0.04 mA/cm2; estimated total charge 0.048C/cm2) in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be oral and written naming.
Other Name: Active tDCS and speech-therapy
Sham Comparator: Sham plus Speech-Language Therapy
Sham tDCS will be applied at the beginning of 45min speech-language therapy session. Language therapy will be oral and written naming. This is a cross-over study so all participants will receive this arm but the order will be randomized.
Device: Sham plus Speech-Language Therapy
Speech-Language therapy will be administered during sham stimulation. Current will be administered in a ramp-line fashion but after the ramping the intensity will drop to 0 mA. Speech-language therapy will be oral and written naming.
Other Name: Sham tDCS plus speech-therapy
- Change in picture naming scores in trained and untrained items [ Time Frame: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups ]
- Change in Philadelphia Naming Test: Picture naming of everyday objects, different from training set [ Time Frame: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups ]
- Change in Written naming of objects and actions [ Time Frame: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups ]We will evaluate the absolute number as well as the percent change of the list of objects and actions assigned for intervention as trained and untrained items.
- Change in working memory (digit span) [ Time Frame: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups ]
- Change in verbal fluency [ Time Frame: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups ]We will use letter (F, A, S) and semantic fluency measures (animals, fruits and vegetables) and we will measure how many were added or omitted at follow-up intervals.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02622945
|Contact: Kyrana Tsapkini, PhDemail@example.com|
|Contact: Argye Hillis, MDfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Medicine||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Argye Hillis, MD 410-614-2381 email@example.com|
|Principal Investigator: Kyrana Tsapkini, PhD|
|Principal Investigator: Argye Hillis, MD|
|Sub-Investigator: Rajani Sebastian, PhD|