A Phase 1 interventional study of Transcranial Direct Current Stimulation - Cathodal stimulation and Transcranial Direct Current Stimulation - Anodal stimulation in Nonfluent Aphasia and Stroke, sponsored by Shirley Ryan AbilityLab. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2017-05-15.
Sponsored by Shirley Ryan AbilityLab · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the effectiveness of small amounts of electrical current, applied without surgery to the brain, in combination with speech-language treatment, on the language outcome of study subjects with nonfluent aphasia (i.e. difficulty with the comprehension and expression of spoken and written language) following a stroke.
Stroke is the third leading cause of death and the most common cause of disability in the United States. According to the American Stroke Association, the prevalence of stroke in the U.S. is approximately 4.8 million with approximately 700,000 additional strokes occurring annually. Approximately 150,000 to 250,000 stroke survivors becoming severely and permanently disabled each year.
A common neurological deficit among stroke survivors, and thus a substantial contributor to post-stroke disability, is aphasia. The loss of, or difficulty with language is extremely debilitating and has enormous social and economic impact on quality of life. Presently, the only treatment available for persons with aphasia is speech-language rehabilitation.
With rehabilitation only, however, many patients achieve a less than satisfactory improvement in speech-language function, and thus are left with significant disability.
Enhancing stroke recovery by facilitating brain plasticity with the direct application of stimulation to the cerebral cortex is a new area of investigation and shows promise for improving language recovery in stroke-induced aphasia, most probably when it is combined with intense learning. There are several methods of delivering cortical brain stimulation to modulate cortical excitability, each of which have been studied in animal models with promising results, and subsequently applied to the rehabilitation of motor deficits after stroke. Applications to language problems after stroke are only emerging. Nevertheless, results suggest a potential role for cortical stimulation as an adjuvant strategy in aphasia rehabilitation.
Of the cortical stimulation methods available, transcranial direct current stimulation (tDCS) has the greatest potential for clinical use in view of its non-invasive application, ease of administration and relatively low cost. tDCS is a method of delivering weak polarizing electrical currents to the cortex via two electrodes placed on the scalp. The nature of the effect depends on the polarity of the current. Anodal tDCS has an excitatory effect; cathodal tDCS induces inhibition.
This study proposes to evaluate the safety, feasibility, and effectiveness of anodal and cathodal tDCS in study subjects with Broca's aphasia after stroke, delivered concurrent with speech-language rehabilitation.
Subjects will receive speech and language therapy combined with either anodal, cathodal, or sham stimulation applied to the lesioned left hemisphere. The polarity conditions will be compared with each other and with sham stimulation, to determine safety, the degree to which improvements in language performance occur, and the degree to which they are maintained over time.
The protocol is single-blind. Neither the subjects nor the outcomes assessor will know what stimulation the subject received until the study's conclusion; the investigator applying the stimulation will know.
43 studies on the registry are indexed under Aphasia, Broca; 13 are open to participants now.
This study's planned enrollment of 12 is below the median of 30 across 39 interventional studies indexed under Aphasia, Broca.
Browse Aphasia, Broca studies →Shirley Ryan AbilityLab is the lead sponsor of 180 studies on the registry; 44 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 4 (40%) have results posted.
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Exclusion Criteria:
Device: Transcranial Direct Current Stimulation - Anodal stimulation
Device: Transcranial Direct Current Stimulation - Cathodal stimulation
Device: Transcranial Direct Current Stimulation - Sham stimulation
Cathodal transcranial direct stimulation (tDCS) to the left hemisphere, 1.0 mA for 13 minutes, is received five days a week, for six weeks, during the initial 13 minutes of 90 minutes of speech-language treatment.
Also known as: Cortical stimulation, Transcranial direct current stimulation
Anodal transcranial direct stimulation (tDCS) to the left hemisphere, 1.0 mA for 13 minutes, is received five days a week, for six weeks, during the initial 13 minutes of 90 minutes of speech-language treatment.
Also known as: Cortical stimulation, Transcranial direct current stimulation
Sham stimulation provided together with 90 minutes of speech language therapy, 5 days a week, for 6 weeks.
Also known as: No stimulation
Aphasia Quotient (AQ) on the Western Aphasia Battery
Time frame: Change from Baseline in Western Aphasia Battery at 6 weeks
Functional communication skills
Scores derived from language sample analyses
Time frame: Change from Baseline in functional communication skills at 6 weeks
Participation in everyday activities
Measures on CETI, BOSS, CCRSA
Time frame: Change from Baseline in participation in everyday activities at 6 weeks
Western Aphasia Battery - Reading and Writing scores
Time frame: Change from Baseline in Western Aphasia Battery Reading and Writing scores at 6 weeks
Western Aphasia Battery Aphasia Quotient (Maintenance)
Time frame: Change in Western Aphasia Battery AQ from 6 weeks to 12 weeks
Western Aphasia Battery Reading and Writing Scores (Maintenance)
Time frame: Change in WAB Reading and Writing Skills from 6 weeks to 12 weeks
Functional Communication Skills (Maintenance)
Time frame: Communication skills from 6 weeks to 12 weeks
Participation in everyday activities (Maintenance)
Time frame: Change in participation in everyday activities from 6 weeks to 12 weeks
The record gives a start of Mar 2010, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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