RECRUITING

Brain Stimulation Effects on Post-Stroke Fatigue and Aphasia

Conditions

Aphasia Following Cerebral Infarction Stroke Ischemic Fatigue Symptom aphasia fatigue post-stroke fatigue tDCS brain stimulation language treatment language therapy speech therapy speech-language therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-04

Study Completion:2029-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07151677

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Ellyn Riley

CONTACT

315-443-8688

aphasia@syr.edu

Study Locations (Sites)

University of Michigan

Ann Arbor, Michigan, 48109

United States

Syracuse University

Syracuse, New York, 13244

United States

Collaborators and Investigators

Sponsor: Syracuse University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-04

Study Completion Date2029-11

Study Record Updates

Study Start Date2025-08-04

Study Completion Date2029-11

Terms related to this study

Keywords Provided by Researchers

aphasia
fatigue
post-stroke fatigue
tDCS
brain stimulation
language treatment
language therapy
speech therapy
speech-language therapy

Additional Relevant MeSH Terms

Aphasia Following Cerebral Infarction
Stroke Ischemic
Fatigue Symptom