tDCS and Aphasia Treatment
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| ClinicalTrials.gov Identifier: NCT01922245 |
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Recruitment Status :
Completed
First Posted : August 14, 2013
Last Update Posted : August 14, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Aphasia | Device: Soterix 1x1 tDCS | Not Applicable |
Aphasia, commonly defined as impairment or loss of language functions, is a frequent and often chronic consequence of stroke, with detrimental effects on patient autonomy and health-related quality of life (HRQOL). Although beneficial in some cases, the effectiveness of behavioral therapy is often limited, and therefore new complementary treatments must be developed in order to improve rehabilitation of post-stroke aphasia.
In most individuals, language areas in the brain are localized in the left hemisphere. After stroke, there is evidence that the brain reorganizes such that either areas close to damaged language areas in the Left Hemisphere, or anatomically similar areas in the Right Hemisphere, are recruited to perform language tasks.
Recently, studies have begun to examine the effects of non-invasive brain stimulation on aphasia rehabilitation. One such technique is transcranial direct current stimulation (tDCS), which involves administering weak electrical currents through surface electrodes on the scalp. The effects can either stimulate an area, or inhibit an area of the brain. The main hypothesis is that stimulating language areas in the Left Hemisphere in conjunction with speech language therapy will facilitate reorganization of language-relevant areas of the brain, and improve expression.
The proposed study will compare the effects of transcranial direct current stimulation (tDCS) activating language centers in the Left Hemisphere and sham tDCS, in right-handed individuals with chronic post-stroke aphasia. This study will provide information on the effects of tDCS, in conjunction with speech-language therapy, on aphasia rehabilitation.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Double (Participant, Care Provider) |
| Primary Purpose: | Treatment |
| Official Title: | tDCS and Aphasia Treatment |
| Study Start Date : | July 2013 |
| Actual Primary Completion Date : | January 2016 |
| Actual Study Completion Date : | January 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: anodal tDCS
Soterix 1x1 device: anodal tDCS administered to the left hemisphere
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Device: Soterix 1x1 tDCS
Anodal and sham tDCS will be administered. All of the participants will also receive behavioral speech-language therapy. |
- change in naming performance in singles words and sentence context [ Time Frame: change from baseline naming performance at two weeks and four weeks post treatment ]Naming will be tested using standardized tests such at the Boston Naming Test and or the Philadelphia Naming Test. In addition, sentence probes have been created that will assess naming in the sentence context throughout the study.
- change in sentence production [ Time Frame: change from baseline performance at two weeks and four weeks post treatment ]Sentence production will be classified.
- change in health related quality of life [ Time Frame: change from baseline performance at two weeks and four weeks post treatment ]Scales of health related quality of life will be implemented.
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| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: single left hemisphere stroke, more than three months post stroke, right handed, no other medical problems, ages 18-100 -
Exclusion Criteria: more than one stroke, less than three months post stroke, other medical problems, pacemaker or other electronic implant (e.g. hip replacement), pregnancy
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01922245
| United States, New York | |
| Hunter College Brookdale Campus | |
| New York, New York, United States, 10010 | |
| Principal Investigator: | Elizabeth E Galletta, PhD | Hunter College/City University of NY |
Other Publications:
| Responsible Party: | Elizabeth Galletta, PhD, Assistant Professor, Hunter College of City University of New York |
| ClinicalTrials.gov Identifier: | NCT01922245 |
| Other Study ID Numbers: |
062951 |
| First Posted: | August 14, 2013 Key Record Dates |
| Last Update Posted: | August 14, 2020 |
| Last Verified: | August 2020 |
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aphasia therapy stroke language |
naming quality of life tDCS treatment |
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Aphasia Speech Disorders Language Disorders Communication Disorders |
Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases |