Stroke Clinical Trial
Official title:
A Randomized Clinical Trial of tDCS to Remediate Phonological Impairment in Aphasia
This study will investigate the effects of mild electrical stimulation in conjunction with speech therapy for people with post-stroke aphasia to enhance language recovery.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | January 1, 2033 |
Est. primary completion date | January 1, 2033 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Patients must be 18 or older. Patients may not be older than 85. Patients must have a language deficit from left-sided focal neurologic damage (e.g. stroke, tumor). Patients must be adults and have English-language fluency. Patients must be eligible to undergo MRI. Beyond meeting the inclusion criteria, no preference will be given on the basis of race, ethnicity or gender. Exclusion Criteria: - Advanced neurodegenerative disease (i.e. Stage 3 Alzheimer's disease) Neurologic disease (e.g. idiopathic epilepsy, seizure disorders that are not well managed, Parkinson's disease, ALS), Severe psychopathology (e.g. schizophrenia, bipolar disorder, acute major depressive episode) Suspected or diagnosed uncorrectable hearing or vision difficulties, or developmental disabilities (i.e. intellectual disability or learning disability). Contraindications to MRI such as claustrophobia, implanted electronic devices, MRI-incompatible metal in the body, extreme obesity, pregnancy, inability to lie flat, inability to see or hear stimulus materials. Younger than 18 or older than 85. < 6 months post tumor resection. |
Country | Name | City | State |
---|---|---|---|
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin |
United States,
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* Note: There are 34 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Behavioral outcome | Percent improvement on behavioral outcomes after each therapy cycle will be the primary behavioral outcome measure. | Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post completion of therapy | |
Secondary | fMRI | fMRI functional changes between time points | 3 time points: pre-assessment, 10 weeks post-therapy cycle A and 10 weeks post-therapy cycle B |
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