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

Pre-Frontal tDCS as a Novel Intervention to Reduce Effects of Post-Stroke Fatigue While Improving Language and Attention in Aphasia

This trial tests whether mild electrical stimulation (tDCS) to the front of the brain combined with speech therapy can reduce fatigue and improve language and attention in people with chronic left-hemisphere ischemic stroke and mild-to-moderate aphasia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Syracuse University (Academic / other)
• Locations: 2 sites (Ann Arbor, Michigan and 1 other locations)
• Trial ID: NCT07151677 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults at least 6 months after a single left-hemisphere ischemic stroke with mild-to-moderate aphasia, self-reported post-stroke fatigue, intact left dorsolateral prefrontal cortex, no recent seizures, and no contraindicating implants or concurrent targeted speech therapy.

Not a fit: People with severe aphasia, bilateral or non-ischemic strokes, damage overlapping the targeted left DLPFC, recent seizures, uncontrolled neurological or psychiatric conditions, or contraindicated implants/pacemakers (or pregnancy) are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this could provide a noninvasive, low-risk option to lessen post-stroke fatigue and improve language and attention when paired with speech therapy.

How similar studies have performed: Previous small randomized and pilot studies of tDCS for post-stroke language and fatigue have shown mixed but promising results, so this builds on pilot data rather than representing an untested approach.

Eligibility criteria

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 this trial is running

Ann Arbor, Michigan and 1 other locations

• University of Michigan — Ann Arbor, Michigan, United States (Not_yet_recruiting)
• Syracuse University — Syracuse, New York, United States (Recruiting)

Study contacts

• Study coordinator: Ellyn Riley

Conditions Aphasia Following Cerebral Infarction; Stroke Ischemic; Fatigue Symptom; aphasia; fatigue; post-stroke fatigue; tDCS; brain stimulation