Brain Stimulation Effects on Post-Stroke Fatigue and Aphasia

Syracuse University

Status: Enrolling

Conditions: Fatigue Symptom; Stroke Ischemic; Aphasia Following Cerebral Infarction

Treatments: Device: tDCS (sham); Behavioral: Attention-focused sentence comprehension treatment; Device: tDCS (active); Behavioral: Sentence comprehension treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07151677

1R01DC021677-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this clinical trial is to determine if electrical brain stimulation applied to the front parts of the brain can help people who have had a stroke improve their fatigue, language, and attention. The main question it aims to answer is:

• Does transcranial direct current stimulation (tDCS) administered to the pre-frontal areas of the brain improve post-stroke fatigue and aphasia?
• What kinds of participant characteristics are associated with better improvement of post-stroke fatigue and aphasia?

Researchers will compare active electrical stimulation to sham stimulation to see if the active stimulation does a better job at reducing fatigue and language deficits after stroke. Participants will be asked to complete fatigue, language, and cognitive testing before and after receiving 10 sessions of tDCS plus speech and language therapy.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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60 participants in 4 patient groups

active tDCS plus attention-focused language treatment

Experimental group

Description:

active tDCS and attention focused language treatment will be administered

Treatment:

Device: tDCS (active)

Behavioral: Attention-focused sentence comprehension treatment

active tDCS plus sentence picture matching treatment

Active Comparator group

Description:

active tDCS and sentence picture matching treatment will be administered

Treatment:

Behavioral: Sentence comprehension treatment

Device: tDCS (active)

sham tDCS plus attention-focused language treatment

Sham Comparator group

Description:

sham tDCS and attention focused language treatment will be administered

Treatment:

Behavioral: Attention-focused sentence comprehension treatment

Device: tDCS (sham)

sham tDCS plus sentence picture matching treatment

Sham Comparator group

Description:

sham tDCS and sentence picture matching treatment will be administered

Treatment:

Behavioral: Sentence comprehension treatment

Device: tDCS (sham)