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Transcranial Direct Current Stimulation for Post-stroke Fatigue

Recruiting
18 years of age
Both
Phase 2

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Overview

The investigators hypothesize that delivery of anodal tDCS to the left frontal head region will reduce fatigue severity following stroke.

Description

The purpose of this study is to investigate transcranial direct current stimulation (tDCS) as a home-based non-pharmacologic intervention for post-stroke fatigue (PSF). Investigators will perform a double-blind, sham-controlled, randomized clinical trial with 24 subjects; 12 will receive sham stimulation and 12 will receive real stimulation. After a baseline assessment, the tDCS device will be applied for 20 minutes, once daily over the left dorsolateral prefrontal cortex (DLPFC), for a total of two weeks. Follow-up assessments with outcome metrics will be completed after the seventh and fourteenth sessions, and one-month following the start date (2 weeks post-treatment). In a randomly selected subset of both real and sham participants, rs-fMRI will be completed at baseline and post-treatment.

Eligibility

Inclusion Criteria:

  • Male or female patients aged >18 years
  • Greater than 3 months from first hemorrhagic or ischemic stroke (subacute to chronic), confirmed through neuroimaging (CT or MRI).
  • Fatigue severity score average >4 (severe fatigue)
  • Willingness to remain stable on pharmacologic therapy through the duration of the study.
  • Availability of a caregiver, family member, or friend to be present during the administration of the tDCS intervention.

Exclusion Criteria:

  • Metal in the head (except mouth) or implanted cranial or thoracic devices (i.e. pacemaker, DBS stimulator)
  • History of seizure
  • History of moderate to severe traumatic brain injury
  • A score of 10 or more on the PHQ-9 or GAD-7 scale, suggestive of moderate to severe depression/anxiety.
  • A score of less than 21 on the MoCA suggesting major neurocognitive disorder.
  • Signs of skin rash, infection, or laceration in the supraorbital region where the tDCS will be applied.
  • Inability to provide informed consent
  • Other major neurological, medical, or psychiatric illnesses that could confound results in the opinion of the site investigator.

Study details

Fatigue, Stroke Rehabilitaion

NCT05816603

Weill Medical College of Cornell University

29 April 2024

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