Transcranial Direct Current Stimulation for Post-stroke Fatigue

This study is testing if a device called the Soterix Mini-CT tDCS stimulator can help reduce fatigue after a stroke. Researchers believe that using this device to deliver a small electrical current to a specific part of the brain (left dorsolateral prefrontal cortex) might lessen fatigue. You might be able to join if you are over 18, had a stroke more than three months ago, and have severe fatigue (Fatigue Severity Scale average score of over 4). The study aims to see if your fatigue improves based on changes in your Fatigue Severity Scale score over time. The current status of this study is unclear.

Study design: This is a double-blind, sham-controlled, randomized study with 24 participants. Half of the participants will receive real stimulation and half will receive sham (inactive) stimulation.
What's involved: You would have a baseline assessment, then use the tDCS device for 20 minutes daily for two weeks. Follow-up assessments will occur after the first and second weeks of treatment, and one month after the treatment starts.
Compensation: Not stated in the trial record.
Follow-up: You will be followed for about one month after your treatment ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Transcranial Direct Current Stimulation for Post-stroke Fatigue

Recruiting

PHASE2Ages 18+InterventionalTreatment

Weill Medical College of Cornell University

~24 participants

Updated 2026-02-27 on ClinicalTrials.gov

What's tested:Real Soterix Mini-CT tDCS stimulatorSham Soterix Mini-CT tDCS stimulator

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Mean change from baseline Fatigue Severity Scale - 7 (FSS-7)

Measured over Screening (-1 to -14 days), Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52))

Conditions

Fatigue

Stroke Rehabilitaion

NCT05816603

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106
New York, New Yorkstudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Joan M Stilling, MD, MS · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University

Who to contact

Zhiyan Yang, M.A.

[email protected]

(212) 746-1509

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Mean change from baseline Fatigue Severity Scale - 7 (FSS-7)Screening (-1 to -14 days), Baseline (Day 1), During-treatment (Day 7-9), Post-Treatment (Day 14-21), 1 Month Post-Treatment (Day 45-52))
Fatigue Severity. This seven item scale measures fatigue severity and it's effect on a person's lifestyle and activities. Items are scored on a seven point scale. Minimum score = 7, maximum score = 49 with higher score indicating greater fatigue severity.

Trialytics