NCT07151677 · Syracuse University
Brain Stimulation Effects on Post-Stroke Fatigue and Aphasia
What this study is 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.
View original scientific 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.
Interventions
DEVICE
tDCS (active)
The investigators will administer active tDCS to left dorsolateral prefrontal cortex (DLPFC) during 10 sessions of behavioral treatment. For active tDCS, the current will slowly be increased to 2mA and applied for 20 minutes.
BEHAVIORAL
Attention-focused sentence comprehension treatment
This is a specific type of speech-language therapy that focuses on simultaneously improving auditory comprehension and behavioral attention. Participants will receive 10 sessions of this treatment.
BEHAVIORAL
Sentence comprehension treatment
This is a specific type of speech-language therapy that focuses on improving auditory comprehension . Participants will receive 10 sessions of this treatment.
DEVICE
tDCS (sham)
The investigators will administer sham tDCS to left dorsolateral prefrontal cortex (DLPFC) during 10 sessions of behavioral treatment. For sham tDCS, the current will slowly be increased to 2mA over the course of 30 seconds and then immediately ramped back down to zero.
Primary outcome measures
Fatigue Interference and Severity Scale for Aphasia (FISS-A)
Time frame: baseline; within 1 week following the final treatment session; 3- month follow-up
Scale from 1-7, higher scores mean more significant fatigue
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18 years or older.
- No diagnosis of neurological disorder (other than stroke).
- No diagnosis of psychiatric disorder, with the exception of anxiety and/or depression if it is managed through medication and/or behavioral intervention.
- No seizure within the past 6 months.
- Not pregnant.
- Does not currently have cardiac pacemaker
- In chronic phase of recovery, defined as at least 6 months post-stroke.
- Not undergoing speech and language therapy targeting auditory comprehension or attention for the duration of the study.
- No metal implants in the scalp or bone in the pre-frontal area of the head.
- No unhealed skull fractures.
- Onset of aphasia related to single, left hemisphere, ischemic stroke.
- Damaged brain tissue from stroke does not overlap with left hemisphere dorsolateral prefrontal cortex.
- Mild to moderate aphasia (as measured by WAB-R \*\*or QAB).
- Self-report of post-stroke fatigue (as measured on SF-CAT)
- No significant challenges with vision or hearing (with use of corrective aids if needed; eyeglasses, hearing aids).
- Willing to allow audio-recording of study sessions.
Exclusion criteria
- Younger than 18 years old.
- Diagnosis or history of neurological disorder other than stroke.
- Diagnosis or history of psychiatric disorder with the exception of anxiety and/or depression if it is managed through medication and/or behavioral intervention.
- History of seizures within the past 6 months.
- Currently has cardiac pacemaker
- \<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)
- Currently undergoing speech and language therapy targeting auditory comprehension or attention.
- Metal implants in the scalp or bone in the pre-frontal area of the head.
- Currently has an unhealed skull fracture.
- Onset of aphasia related to etiology other than ischemic left hemisphere stroke.
- Damaged brain tissue significantly overlaps with left hemisphere dorsolateral prefrontal cortex.
- No aphasia or severe aphasia (as measured by WAB-R \*\*or QAB).
- Does not report experience of post-stroke fatigue (as measured on SF-CAT)
- Significant challenges with vision and/or hearing (even with use of corrective aids).
- Unwilling to allow audio-recording of study sessions.
Where
- Ann Arbor, Michigan
- Syracuse, New York
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 3, 2025 · Source of record for eligibility and locations