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TDCS to Improve Post-Stroke Cognitive Impairment

RecruitingNAAges 18 Years - 100 YearsAllJohns Hopkins University
NCT05195398 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The investigators will conduct a randomized, double-blinded, sham-controlled trial of approximately 60 patients with minor stroke and post-stroke mild cognitive impairment (psMCI). Participants will be individually randomized on enrollment using a random number generator to treatment with anodal tDCS + computerized cognitive treatment (CCT) versus sham + CCT (approximately 30 patients in each arm). Clinical evaluation including assessment of cognition will be performed pre- and post-intervention by individuals on the study team blinded to the participant's intervention. Participants will also undergo functional neuroimaging with magnetoencephalography (MEG) pre- and post-intervention (1, 3, and 6 months post-stroke to evaluate for initial and longer-term effects of treatment on cerebral activation patterns and functional connectivity). Neuroimaging and clinical outcomes will be assessed

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Adults (≥18 years) presenting with neurological symptoms due to acute ischemic stroke (symptom onset within the week prior to admission). 2. Evidence on brain MRI of acute ischemic stroke (imaging negative strokes and TIAs will be excluded). 3. Native English speaker (by self-report) prior to stroke. 4. NIHSS \<8 at initial follow-up visit (approximately 30 days post-stroke). 5. mRS 0-2 at initial follow-up visit. Exclusion Criteria: 1. Primary intracerebral hemorrhage- as evidenced by blood on head CT or MRI. 2. Presence of proximal large vessel occlusion. 3. Cortical exam findings including aphasia or neglect. 4. Prior report or history of dementia or undertreated psychiatric illness. 5. Uncorrected hearing or visual loss. 6. Inability to attend treatment or follow-up sessions. 7. Inability to travel to College Park (UMD) for MEG recording sessions. 8. Presence of any of the following that would lead to significant artifact on MEG: cardiac pacemaker, intracranial clips, metal implants or external clips within 10mm of the head, metal implants in the eyes (unlikely given that all patients will have an MRI and criteria are similar). 9. Claustrophobia, obesity, and/or any other reason leading to difficulty staying in the MEG machine for up to 1 hour.
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What it tests

  • Anodal transcranial Direct Current Stimulation (A-tDCS)
  • Sham Intervention
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Where

1 site
Johns Hopkins Bayview Medical Center
Baltimore, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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