Prefrontal brain stimulation to reduce post-stroke fatigue and improve aphasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with chronic left-hemisphere ischemic stroke, mild-to-moderate aphasia, and self-reported fatigue are randomized to receive either active transcranial direct current stimulation (tDCS) to prefrontal areas or sham stimulation alongside sentence-comprehension speech therapy. Participants complete standardized fatigue, language (WAB-R or QAB), and cognitive testing before and after 10 treatment sessions. The study compares active versus sham stimulation to see if active tDCS produces greater reductions in fatigue and improvements in language and attention. Researchers will also analyze which participant characteristics are associated with better response to the combined intervention.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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 \*\*or QAB).
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 Criteria:

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 \*\*or QAB).
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.

Where it's running

• Syracuse University
  Syracuse, New York, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Not yet recruiting

Study contacts

• Study coordinator: Ellyn Riley
• Email: aphasia@syr.edu
• Phone: 315-443-8688

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.