Recruiting

tDCS

Sponsor:

Syracuse University

Code:

NCT07151677

Conditions

Aphasia Following Cerebral Infarction

Stroke Ischemic

Fatigue Symptom

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

tDCS (active)

Attention-focused sentence comprehension treatment

Sentence comprehension treatment

tDCS (sham)

Study Details

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.

Conditions

Aphasia Following Cerebral Infarction

Stroke Ischemic

Fatigue Symptom

Study ID

NCT07151677

Start date

Aug 4, 2025

Status verified date

Aug, 2025

Completion date

Nov, 2029

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: active tDCS plus attention-focused language treatment

active tDCS and attention focused language treatment will be administered

active comparator: active tDCS plus sentence picture matching treatment

active tDCS and sentence picture matching treatment will be administered

sham comparator: sham tDCS plus attention-focused language treatment

sham tDCS and attention focused language treatment will be administered

sham comparator: sham tDCS plus sentence picture matching treatment

sham tDCS and sentence picture matching treatment will be administered

Interventions

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.

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.

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.

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 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 ]

Central Contacts and Locations

Central contacts

Ellyn Riley

315-443-8688aphasia@syr.edu

Locations

Syracuse University

Recruiting

Syracuse, New York, United States, 13244

Contacts

Ellyn Riley

315-443-8688aphasia@syr.edu

More Information

Sponsor

Syracuse University

Last update posted

Sep 3, 2025

Last verified

Aug, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Syracuse University on 2025-09-03.