ClinicalTrials.gg
RecruitingNCT07151677Updated Sep 30, 2026

Brain Stimulation Effects on Post-Stroke Fatigue and Aphasia

An interventional study of tDCS (active) and Attention-focused sentence comprehension treatment in Aphasia Following Cerebral Infarction, Stroke Ischemic and Fatigue Symptom, sponsored by Syracuse University. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Syracuse University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Aphasia Following Cerebral Infarction
  • Stroke Ischemic
  • Fatigue Symptom

Keywords

  • aphasia
  • fatigue
  • post-stroke fatigue
  • tDCS
  • brain stimulation
  • language treatment
  • language therapy
  • speech therapy
  • speech-language therapy
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 60 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Syracuse University is the lead sponsor of 33 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    active tDCS plus attention-focused language treatment

    active tDCS and attention focused language treatment will be administered

    Device: tDCS (active) · Behavioral: Attention-focused sentence comprehension treatment

  • Active comparator
    active tDCS plus sentence picture matching treatment

    active tDCS and sentence picture matching treatment will be administered

    Device: tDCS (active) · Behavioral: Sentence comprehension treatment

  • Sham comparator
    sham tDCS plus attention-focused language treatment

    sham tDCS and attention focused language treatment will be administered

    Behavioral: Attention-focused sentence comprehension treatment · Device: tDCS (sham)

  • Sham comparator
    sham tDCS plus sentence picture matching treatment

    sham tDCS and sentence picture matching treatment will be administered

    Behavioral: Sentence comprehension treatment · Device: tDCS (sham)

Interventions

  • DevicetDCS (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.

    Also known as: transcranial direct current stimulation

  • BehavioralAttention-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.

  • BehavioralSentence 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.

  • DevicetDCS (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.

    Also known as: transcranial direct current stimulation

06

What researchers measure

Primary outcomes

  1. Fatigue Interference and Severity Scale for Aphasia (FISS-A)

    Scale from 1-7, higher scores mean more significant fatigue

    Time frame: baseline; within 1 week following the final treatment session; 3- month follow-up

Secondary outcomes

  1. Continuous Performance Test (CPT)

    Time frame: baseline; within 1 week following the final treatment session; 3- month follow-up

  2. Attention Network Test (ANT)

    Time frame: baseline; within 1 week following the final treatment session; 3- month follow-up

  3. Sentence comprehension task

    Time frame: baseline; within 1 week following the final treatment session; 3- month follow-up

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

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 sharing details ↗ · doi.org

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Sep 2029, 49 months after the start.

Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 49 months is above that.

Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2025
First posted
Sep 3, 2025
StartActual
Aug 4, 2025
Primary completionEst.
Sep 2029
CompletionEst.
Nov 2029
Last update
Sep 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07151677
Lead sponsor
Syracuse University
Responsible party
Sponsor
First posted
Sep 3, 2025
Start date
Aug 4, 2025
Primary completion
Sep 2029 (estimated)
Completion
Nov 2029 (estimated)
Last update
Sep 30, 2026

Study contacts

Ellyn Riley
Contact
aphasia@syr.edu
315-443-8688

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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