NCT05195398 TDCS to Improve Post-Stroke Cognitive Impairment
| NCT ID | NCT05195398 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2026-08-31 |
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.
This trial targets 60 participants in total. It began in 2022-09-01 with a primary completion date of 2026-08-31.
⚠ 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 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 to determine the effect of tDCS versus sham + CCT on psMCI.
Eligibility Criteria
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.
Contact & Investigator
Elisabeth B Marsh, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT05195398 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05195398 currently recruiting?
Yes, NCT05195398 is actively recruiting participants. Contact the research team at ebmarsh@jhmi.edu for enrollment information.
Where is the NCT05195398 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT05195398 clinical trial?
NCT05195398 is sponsored by Johns Hopkins University. The principal investigator is Elisabeth B Marsh, MD at Johns Hopkins University. The trial plans to enroll 60 participants.
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