RecruitingPhase 2NCT05816603

Transcranial Direct Current Stimulation for Post-stroke Fatigue

Home-based Post-stroke Fatigue Treatment Using Transcranial Direct Current Stimulation (tDCS)

Sponsor

Weill Medical College of Cornell University

Enrollment

24 participants

Start Date

May 23, 2023

Study Type

INTERVENTIONAL

Conditions

Fatigue Stroke Rehabilitaion

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria8

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.

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Interventions

DEVICEReal Soterix Mini-CT tDCS stimulator

Real transcranial electrical stimulation at 2mA intensity will be delivered to the left dorsolateral prefrontal cortex, 20 minutes/day, 14-day duration.

DEVICESham Soterix Mini-CT tDCS stimulator

Sham stimulation to the left dorsolateral prefrontal cortex, 20 minutes/day, 14-day duration. The device will ramp up and ramp down current delivery from 0 mA -2 mA - 0 mA over 30 seconds at the start of the 20-minute protocol with no active stimulation until the end of the 20 minutes, at which time the 30-second ramp up/ramp down will be repeated.