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NCT05816603PHASE2Recruiting

Transcranial Direct Current Stimulation for Post-stroke Fatigue

Weill Medical College of Cornell University

Start Date

5/23/2023

Completion Date

12/1/2027

Summary

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

Detailed 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). Neuroimaging will be completed at baseline and post-treatment.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

Real Soterix Mini-CT tDCS stimulator

DEVICE

Sham Soterix Mini-CT tDCS stimulator

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Conditions

FatigueStroke Rehabilitaion

Locations

Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106

New York, New York 10065

United States