Pre-Frontal tDCS as a novel intervention to reduce effects of post-stroke fatigue while improving language and attention in aphasia

Study Description:
The Syracuse University Aphasia Lab in New York and the University of Michigan Aphasia Program are recruiting participants for a research study investigating brain stimulation to help reduce fatigue and improve language and cognitive recovery for people after a stroke. Transcranial Direct Current Stimulation (tDCS), a safe non-invasive type of electrical brain stimulation, will be used while participants receive speech and language therapy. Individuals who are 1) at least 18 years old, 2) have had a stroke, and 3) have experienced speech/language difficulties following their stroke are invited to take a brief, 5-minute screening questionnaire to determine eligibility for language and cognitive testing. The questionnaire is available by going to https://redcap.link/post-stroke-fatigue. If eligible based on screening questions, the participant will be scheduled for a 1-2 hour language and cognitive testing session either in-person, if nearby one of the campuses, or over Zoom to determine eligibility for study treatment. If eligible for study treatment, participants will be asked to complete 1 pre-testing session, 10 language training sessions with tDCS, and 2 post-testing sessions, each of which will last between 1-2 hours. Eligible participants will be compensated up to $200 for completion of the study. Eligibility will be determined by the screening questionnaire and results of the initial language and cognitive testing. To learn more about the research, please contact Dr. Ellyn Riley at (315) 443-8688, contact aphasia@syr.edu, or visit aphasialab.syr.edu. The Aphasia Lab is located on the Syracuse University South Campus at 621 Skytop Road in Syracuse, NY; the University of Michigan Aphasia Program is located at 1111 Catherine St. in Ann Arbor, MI.
Aphasia Friendly Study Description:
The Syracuse University Aphasia Lab and the University of Michigan Aphasia Program are looking for participants in a study about brain stimulation to reduce fatigue and improve language and thinking skills after a stroke. They will use a safe type of brain stimulation called Transcranial Direct Current Stimulation (tDCS) during speech therapy sessions. People who are at least 18 years old, have had a stroke, and have language difficulties after their stroke can take a 5-minute questionnaire to see if they’re eligible for testing. The questionnaire is available at https://redcap.link/post-stroke-fatigue. If eligible, participants will have a 1-2 hour session for language and cognitive testing, either in person or over Zoom. If they qualify for the study, they will do 1 pre-test session, 10 language therapy sessions with tDCS, and 2 post-test sessions. Each session lasts 1-2 hours. Participants can earn up to $200 for completing the study. To learn more, contact Dr. Ellyn Riley at (315) 443-8688, aphasia@syr.edu, or visit aphasialab.syr.edu. The Syracuse Aphasia Lab is at 621 Skytop Road, Syracuse, NY, and the University of Michigan Aphasia Program is at 1111 Catherine St., Ann Arbor, MI.
Inclusion / Exclusion Criteria:
Inclusion: 1. 18 years or older. 2. No diagnosis of neurological disorder (other than stroke). 3. No diagnosis of psychiatric disorder, with the exception of anxiety and/or depression if it is managed through medication and/or behavioral intervention. 4. No seizure within the past 6 months. 5. Not pregnant. 6. Does not currently have cardiac pacemaker 7. In chronic phase of recovery, defined as at least 6 months post-stroke. 8. Not undergoing speech and language therapy targeting auditory comprehension or attention for the duration of the study. 9. No metal implants in the scalp or bone in the pre-frontal area of the head. 10. No unhealed skull fractures. 11. Onset of aphasia related to single, left hemisphere, ischemic stroke. 12. Damaged brain tissue from stroke does not overlap with left hemisphere dorsolateral prefrontal cortex. 13. Mild to moderate aphasia (as measured by WAB-R). 14. Self-report of post-stroke fatigue (as measured on SF-CAT) 15. No significant challenges with vision or hearing (with use of corrective aids if needed; eyeglasses, hearing aids). 16. Willing to allow audio-recording of study sessions. Exclusion: 1. Younger than 18 years old. 2. Diagnosis or history of neurological disorder other than stroke. 3. Diagnosis or history of psychiatric disorder with the exception of anxiety and/or depression if it is managed through medication and/or behavioral intervention. 4. History of seizures within the past 6 months. 5. Pregnant. 6. Currently has cardiac pacemaker 7. <6 months post-stroke (however, if this is only exclusionary criterion met, participant can be re-evaluated at the 6-month mark if still interested in the study) 8. Currently undergoing speech and language therapy targeting auditory comprehension or attention. 9. Metal implants in the scalp or bone in the pre-frontal area of the head. 10. Currently has an unhealed skull fracture. 11. Onset of aphasia related to etiology other than ischemic left hemisphere stroke. 12. Damaged brain tissue significantly overlaps with left hemisphere dorsolateral prefrontal cortex. 13. No aphasia or severe aphasia (as measured by WAB-R). 14. Does not report experience of post-stroke fatigue (as measured on SF-CAT) 15. Significant challenges with vision and/or hearing (even with use of corrective aids). 16. Unwilling to allow audio-recording of study sessions.
Principal Investigator:
Ellyn Riley
Contact Email:
aphasia@syr.edu
Condition
Stroke
Observational or Treatment:
Treatment
Type of Treatment:
Brain stimulation (tDCS) & language treatment
Duration of Study:
1-Screening procedure (approximately 5-10 min); online 2-Study eligibility language and cognitive testing session (2 hrs) 3-Pre-treatment testing/data collection session (2 hrs) 4-Treatment sessions: tDCS paired with language or attention/language treatment (1.5 hrs each; 10 sessions) 5-Post-treatment testing/data collection session (2 hrs; to be collected within 1 week of last treatment session); 6-Follow up testing/data collection session (2 hrs; to be collected 3 months after last treatment session)
Study Start Date:
December 1, 2024
Study End Date:
December 1, 2029
Costs or Reimbursement:
Participants who pass the initial eligibility screening will receive compensation of a digital Amazon gift card valued up to $200 for completing this study. All participants who complete eligibility testing will receive $15, those who qualify for the study and are enrolled in treatment will be compensated gift card value of $12 per treatment session, $15 for pre-testing (total will remain $15 even if participant requests the 2 hour session be split across 2 days), $15 for post-testing (total will remain $15 even if participant requests the 2 hour session be split across 2 days), $15 the final follow-up testing session, and a $20 completion bonus. Payment will be provided via digital Amazon gift card at the end of the individual's participation in the study.
IRB Approval #
24236
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