NCT05816603 Transcranial Direct Current Stimulation for Post-stroke Fatigue
| NCT ID | NCT05816603 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Fatigue |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-05-23 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2023-05-23 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators hypothesize that delivery of anodal tDCS to the left frontal head region will reduce fatigue severity following stroke.
Eligibility Criteria
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.
Contact & Investigator
Joan M Stilling, MD, MS
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT05816603 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fatigue. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05816603 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05816603 currently recruiting?
Yes, NCT05816603 is actively recruiting participants. Contact the research team at rehabresearch@med.cornell.edu for enrollment information.
Where is the NCT05816603 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05816603 clinical trial?
NCT05816603 is sponsored by Weill Medical College of Cornell University. The principal investigator is Joan M Stilling, MD, MS at Weill Medical College of Cornell University. The trial plans to enroll 24 participants.