Recruiting
Phase 2

Transcranial Direct Current Stimulation

Sponsor:

Weill Medical College of Cornell University

Code:

NCT05816603

Conditions

Fatigue

Stroke Rehabilitaion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Real Soterix Mini-CT tDCS stimulator

Sham Soterix Mini-CT tDCS stimulator

Study Details

Brief summary:

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

Conditions

Fatigue

Stroke Rehabilitaion

Study ID

NCT05816603

Start date

May 23, 2023

Status verified date

Feb, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Real tDCS stimulation

Subjects randomized to receive real/active electrical stimulation.

sham comparator: Sham tDCS stimulation

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

Interventions

Real 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.

Sham 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.

Primary outcome measure

  • Mean change from baseline Fatigue Severity Scale - 7 (FSS-7) [ Time Frame: 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)) ]

Central Contacts and Locations

Central contacts

Zhiyan Yang, M.A.

(212) 746-1509rehabresearch@med.cornell.edu

Locations

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

Recruiting

New York, New York, United States, 10065

Contacts

Zhiyan Yang, M.A.

(212) 746-1509rehabresearch@med.cornell.edu

Principal Investigator:

Joan Stilling, MD, MS

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-02-27.