Aphasia Following Cerebral InfarctionNCT07151677
Brain Stimulation Effects on Post-Stroke Fatigue and Aphasia
A study testing tDCS (active), Attention-focused sentence comprehension treatment and Sentence comprehension treatment in people with Aphasia Following Cerebral Infarction and Stroke Ischemic, run by Syracuse University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphasia Following Cerebral Infarction, Stroke Ischemic, Fatigue Symptom
- What is being tested?
- tDCS (active), Attention-focused sentence comprehension treatment and Sentence comprehension treatment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Aug 2025to Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- <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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Carol Persad, 734-615-8112, cpersad@umich.edu
- Recruiting
Syracuse University
Syracuse, New York, 13244
Ellyn Riley, 315-443-8688, aphasia@syr.edu
About this study
Official title: Pre-Frontal tDCS as a Novel Intervention to Reduce Effects of Post-Stroke Fatigue While Improving Language and Attention in Aphasia
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.
- Being tested
- tDCS (active), Attention-focused sentence comprehension treatment, Sentence comprehension treatment, tDCS (sham)
- Keywords
- aphasia, fatigue, post-stroke fatigue, tDCS, brain stimulation, language treatment, language therapy, speech therapy, speech-language therapy
- Medical subject headings
- Ischemic Stroke, Fatigue, Aphasia, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS (active)Device
Also called transcranial direct current stimulation
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.
Attention-focused sentence comprehension treatmentBehavioural
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.
Sentence comprehension treatmentBehavioural
This is a specific type of speech-language therapy that focuses on improving auditory comprehension . Participants will receive 10 sessions of this treatment.
tDCS (sham)Device
Also called transcranial direct current stimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| active tDCS plus attention-focused language treatment | Experimental | active tDCS and attention focused language treatment will be administered Receives: Device: tDCS (active); Behavioral: Attention-focused sentence comprehension treatment |
| active tDCS plus sentence picture matching treatment | Active comparator | active tDCS and sentence picture matching treatment will be administered Receives: Device: tDCS (active); Behavioral: Sentence comprehension treatment |
| sham tDCS plus attention-focused language treatment | Sham comparator | sham tDCS and attention focused language treatment will be administered Receives: Behavioral: Attention-focused sentence comprehension treatment; Device: tDCS (sham) |
| sham tDCS plus sentence picture matching treatment | Sham comparator | sham tDCS and sentence picture matching treatment will be administered Receives: Behavioral: Sentence comprehension treatment; Device: tDCS (sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Interference and Severity Scale for Aphasia (FISS-A)
Scale from 1-7, higher scores mean more significant fatigue
Measured: baseline; within 1 week following the final treatment session; 3- month follow-up
Secondary outcomes (3)
Continuous Performance Test (CPT)
Measured: baseline; within 1 week following the final treatment session; 3- month follow-up
Attention Network Test (ANT)
Measured: baseline; within 1 week following the final treatment session; 3- month follow-up
Sentence comprehension task
Measured: baseline; within 1 week following the final treatment session; 3- month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start4 Aug 2025
- Primary completionSep 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphasia Following Cerebral InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syracuse University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151677
- Sponsor's protocol ID
- 1R01DC021677-01A1
- Other IDs
- 1R01DC021677-01A1
- Status last verified
- Sep 2026
- First submitted
- 18 Aug 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Frontal tDCS as a Novel Intervention to Reduce Effects of Post-Stroke Fatigue While Improving Language and Attention in Aphasia
- ClinicalTrials.gov ID
- NCT07151677
- Acronym / sponsor ID
- 1R01DC021677-01A1
- Keywords
- aphasia, fatigue, post-stroke fatigue, tDCS, brain stimulation, language treatment, language therapy, speech therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Syracuse UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| active tDCS plus attention-focused language treatment | Experimental | Device: tDCS (active), Behavioral: Attention-focused sentence comprehension treatmentactive tDCS and attention focused language treatment will be administered |
| active tDCS plus sentence picture matching treatment | Active comparator | Device: tDCS (active), Behavioral: Sentence comprehension treatmentactive tDCS and sentence picture matching treatment will be administered |
| sham tDCS plus attention-focused language treatment | Sham comparator | Behavioral: Attention-focused sentence comprehension treatment, Device: tDCS (sham)sham tDCS and attention focused language treatment will be administered |
| sham tDCS plus sentence picture matching treatment | Sham comparator | Behavioral: Sentence comprehension treatment, Device: tDCS (sham)sham tDCS and sentence picture matching treatment will be administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS (active)Also: transcranial direct current stimulationThe 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. | Device | active tDCS plus attention-focused language treatment, active tDCS plus sentence picture matching treatment |
| Attention-focused sentence comprehension treatmentThis 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. | Behavioural | active tDCS plus attention-focused language treatment, sham tDCS plus attention-focused language treatment |
| Sentence comprehension treatmentThis is a specific type of speech-language therapy that focuses on improving auditory comprehension . Participants will receive 10 sessions of this treatment. | Behavioural | active tDCS plus sentence picture matching treatment, sham tDCS plus sentence picture matching treatment |
| tDCS (sham)Also: transcranial direct current stimulationThe 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. | Device | sham tDCS plus attention-focused language treatment, sham tDCS plus sentence picture matching treatment |
Primary outcome
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
3 secondary outcomes
Continuous Performance Test (CPT)
Time frame: baseline; within 1 week following the final treatment session; 3- month follow-up
Attention Network Test (ANT)
Time frame: baseline; within 1 week following the final treatment session; 3- month follow-up
Sentence comprehension task
Time frame: baseline; within 1 week following the final treatment session; 3- month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Aphasia Following Cerebral Infarction
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BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia
Expressive Aphasia, Aphasia Following Cerebral Infarction
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Comparing Traditional Semantic Feature Analysis (tSFA) and Semantic Feature Analysis + Metacognitive Strategy Training (SFA+MST)
Aphasia, Aphasia Following Cerebral Infarction
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Transcranial Magnetic Stimulation + Language Therapy to Treat Subacute Aphasia
Stroke, Aphasia
Not yet recruiting
Intensive Comprehensive Aphasia Programme for People With Post-Stroke Aphasia
Aphasia Following Cerebral Infarction
Not yet recruitingPhase 3
EFFECT OF ANODAL TRANSCRANIAL DIRECT CURRENT STIMULATION ON NAMING IN APHASIC PATIENTS WITH ACUTE ISCHEMIC STROKE
Acute Ischemic Cerebrovascular Disease, Post Stroke Aphasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS (active), Attention-focused sentence comprehension treatment and Sentence comprehension treatment in people with Aphasia Following Cerebral Infarction and Stroke Ischemic, run by Syracuse University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellyn Riley (315-443-8688, aphasia@syr.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Interference and Severity Scale for Aphasia (FISS-A) (time frame: baseline; within 1 week following the final treatment session; 3- month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.