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TDCS to Improve Post-Stroke Cognitive Impairment

NCT05195398 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-16

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Anodal transcranial Direct Current Stimulation (A-tDCS)

Participants randomized to tDCS will undergo 5 weeks of A-tDCS + CCT.

DEVICE

Sham Intervention

Participants randomized to sham-intervention will undergo 5 weeks of sham + CCT.

Sponsors & Collaborators

  • University of Maryland, College Park

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Elisabeth B Marsh, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2026-08-31
Completion
2027-08-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05195398 on ClinicalTrials.gov