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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05195398
Other study ID # IRB00315010
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date August 31, 2027

Study information

Verified date September 2023
Source Johns Hopkins University
Contact Elisabeth B Marsh, MD
Phone 410-550-8703
Email ebmarsh@jhmi.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Device:
Anodal transcranial Direct Current Stimulation (A-tDCS)
Participants randomized to tDCS will undergo 5 weeks of A-tDCS + CCT.
Sham Intervention
Participants randomized to sham-intervention will undergo 5 weeks of sham + CCT.

Locations

Country Name City State
United States Johns Hopkins Bayview Medical Center Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University University of Maryland, College Park

Country where clinical trial is conducted

United States, 

References & Publications (3)

Marsh EB, Brodbeck C, Llinas RH, Mallick D, Kulasingham JP, Simon JZ, Llinas RR. Poststroke acute dysexecutive syndrome, a disorder resulting from minor stroke due to disruption of network dynamics. Proc Natl Acad Sci U S A. 2020 Dec 29;117(52):33578-33585. doi: 10.1073/pnas.2013231117. Epub 2020 Dec 14. — View Citation

Marsh EB, Lawrence E, Hillis AE, Chen K, Gottesman RF, Llinas RH. Pre-stroke employment results in better patient-reported outcomes after minor stroke: Short title: Functional outcomes after minor stroke. Clin Neurol Neurosurg. 2018 Feb;165:38-42. doi: 10.1016/j.clineuro.2017.12.020. Epub 2017 Dec 27. — View Citation

Sharma R, Mallick D, Llinas RH, Marsh EB. Early Post-stroke Cognition: In-hospital Predictors and the Association With Functional Outcome. Front Neurol. 2020 Dec 23;11:613607. doi: 10.3389/fneur.2020.613607. eCollection 2020. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Cognition as assessed by our Cognitive Battery Our cognitive battery was designed to efficiently evaluate for psMCI. It combines the Montreal Cognitive Assessment, Grooved Pegboard, Hopkins Verbal Learning Test, Brief Visuospatial Memory Test, Delis-Kaplan Executive Function System, and Symbol Digit Modalities Test. T scores are averaged across tasks and calculated for the following cognitive domains: verbal memory, spatial memory, processing speed, motor speed, executive function, and global cognition. Administered at 1, 3, and 6 month post-stroke visits
Primary Change in Functional Connectivity as assessed by MEG Participants will undergo an MEG evaluating global functional connectivity: 1) during resting state, and 2) during completion of a visual task. Connectivity will also be evaluated within the following specific cognitive networks: frontoparietal (executive) and limbic (memory) Administered at 1, 3, and 6 month post-stroke visits
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