Brain Stimulation Effects on Post-Stroke Fatigue and Aphasia
Pre-Frontal tDCS as a Novel Intervention to Reduce Effects of Post-Stroke Fatigue While Improving Language and Attention in Aphasia
1 other identifier
interventional
60
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2025
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 4, 2025
CompletedFirst Submitted
Initial submission to the registry
August 18, 2025
CompletedFirst Posted
Study publicly available on registry
September 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2029
September 3, 2025
August 1, 2025
4.1 years
August 18, 2025
August 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fatigue Interference and Severity Scale for Aphasia (FISS-A)
Scale from 1-7, higher scores mean more significant fatigue
baseline; within 1 week following the final treatment session; 3- month follow-up
Secondary Outcomes (3)
Continuous Performance Test (CPT)
baseline; within 1 week following the final treatment session; 3- month follow-up
Attention Network Test (ANT)
baseline; within 1 week following the final treatment session; 3- month follow-up
Sentence comprehension task
baseline; within 1 week following the final treatment session; 3- month follow-up
Study Arms (4)
active tDCS plus attention-focused language treatment
EXPERIMENTALactive tDCS and attention focused language treatment will be administered
active tDCS plus sentence picture matching treatment
ACTIVE COMPARATORactive tDCS and sentence picture matching treatment will be administered
sham tDCS plus attention-focused language treatment
SHAM COMPARATORsham tDCS and attention focused language treatment will be administered
sham tDCS plus sentence picture matching treatment
SHAM COMPARATORsham tDCS and sentence picture matching treatment will be administered
Interventions
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.
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.
This is a specific type of speech-language therapy that focuses on improving auditory comprehension . Participants will receive 10 sessions of this treatment.
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.
Eligibility Criteria
You may qualify if:
- 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).
- +1 more criteria
You may not qualify if:
- 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.
- Pregnant.
- Currently has cardiac pacemaker
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Syracuse University
Syracuse, New York, 13244, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2025
First Posted
September 3, 2025
Study Start
August 4, 2025
Primary Completion (Estimated)
September 1, 2029
Study Completion (Estimated)
November 1, 2029
Last Updated
September 3, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Shared data and supporting information generated from this project will be made available as soon as possible, and no later than one year following the end of the funding period (11/30/2029). The duration of preservation and sharing of the data will be a minimum of 6 years after the end of the funding period.
- Access Criteria
- Controlled access will not be used. The data that is shared will be shared by unrestricted download. All datasets that can be shared will be deposited in Open Science Framework. Open Science Framework provides searchable study-level metadata for dataset discovery. Open Science Framework assigns DOIs as persistent identifiers and has a robust preservation plan to ensure long-term access. Data will be discoverable online through standard web search of the study-level metadata as well as the persistent pointer from the DOI to the dataset.
Data generated for this project will include participant demographic data, medical information related to the participant's stroke (e.g., date of stroke onset, lesion location), standardized test scores from language and cognitive tests (e.g., Western Aphasia Battery), and outcome measure data. All data will be de-identified.