Transcranial Direct Current Stimulation for Post-stroke Fatigue

Weill Cornell Medicine (WCM)

Status and phase: Enrolling; Phase 2

Conditions: Stroke Rehabilitaion; Fatigue

Treatments: Device: Sham Soterix Mini-CT tDCS stimulator; Device: Real Soterix Mini-CT tDCS stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT05816603

22-11025409

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups

Real tDCS stimulation

Experimental group

Description:

Subjects randomized to receive real/active electrical stimulation.

Treatment:

Device: Real Soterix Mini-CT tDCS stimulator

Sham tDCS stimulation

Sham Comparator group

Description:

Subjects randomized to receive sham/non-activating electrical stimulation.

Treatment:

Device: Sham Soterix Mini-CT tDCS stimulator