Brain Stimulation Effects on Post-Stroke Fatigue and Aphasia

NCT07151677 — Not applicable, Recruiting, 60 participants, Syracuse University

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

RegistryNCT07151677
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, factorial, masking: quadruple, treatment
Enrollment60 (Estimated)
SponsorSyracuse University (Other); collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
ConditionsAphasia Following Cerebral Infarction, Stroke Ischemic, Fatigue Symptom
InterventionstDCS (active), Attention-focused sentence comprehension treatment, Sentence comprehension treatment, tDCS (sham) (Device, behavioral)
Datesstart 2025-08-04, primary completion 2029-09-01 (estimated), completion 2029-11-01 (estimated), first posted 2025-09-03, last updated 2026-09-30
Locations2 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Aphasia Following Cerebral Infarction All trials for Stroke Ischemic All trials of tDCS (active) All trials of Attention-focused sentence comprehension treatment

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
active tDCS plus attention-focused language treatmentExperimentalDevice: tDCS (active); Behavioral: Attention-focused sentence comprehension treatmentactive tDCS and attention focused language treatment will be administered
active tDCS plus sentence picture matching treatmentActive comparatorDevice: tDCS (active); Behavioral: Sentence comprehension treatmentactive tDCS and sentence picture matching treatment will be administered
sham tDCS plus attention-focused language treatmentSham comparatorBehavioral: Attention-focused sentence comprehension treatment; Device: tDCS (sham)sham tDCS and attention focused language treatment will be administered
sham tDCS plus sentence picture matching treatmentSham comparatorBehavioral: Sentence comprehension treatment; Device: tDCS (sham)sham tDCS and sentence picture matching treatment will be administered
  • tDCS (active) (Device), also known as 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 treatment (Behavioral): 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 treatment (Behavioral): 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 known as 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.

+Outcome measures

Primary outcomes

  • Fatigue Interference and Severity Scale for Aphasia (FISS-A) [baseline; within 1 week following the final treatment session; 3- month follow-up]: Scale from 1-7, higher scores mean more significant fatigue

Secondary outcomes

  • 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]

+Eligibility

Sex: All, ages: 18 Years to any

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:

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.

+Locations (2)

FacilityCityCountryStatus
University of MichiganAnn Arbor, MichiganUnited StatesNot yet recruiting
Syracuse UniversitySyracuse, New YorkUnited StatesRecruiting

+Funding

NIH grants: R01DC021677