Brain Stimulation Effects on Post-Stroke Fatigue and Aphasia

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Syracuse University
Study ID
NCT07151677
Status
Recruiting
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Conditions

  • Aphasia Following Cerebral Infarction
  • Fatigue Symptom
  • Stroke Ischemic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • tDCS (active) — DEVICE
    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
    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 Details

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.

Key Dates

Start date
Aug 4, 2025
Status verified
Aug 2025
Primary completion
Sep 30, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

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

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

Locations (2)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Carol Persad
[email protected]
734-615-8112
Syracuse UniversitySyracuseNew York13244
Ellyn Riley
[email protected]
315-443-8688

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By research site
University of Michigan· Ann Arbor, MISyracuse University· Syracuse, NY

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