Imaging Post-Stroke Recovery: Using MEG to Evaluate Cognition

NCT04188522 | Recruiting

• 2 other identifiers: IRB0012222118IPA34170313
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study using magnetoencephalography (MEG) to look at recovery in those with minor stroke. The investigators know that these individuals report difficulties in attention, concentration, multi-tasking, energy level, and processing speed that appear to be independent of lesion size or location. The underlying pathophysiology is unclear; however, anecdotally, many individuals are significantly improved by 6 months post-stroke. One hypothesis is that a single lesion, regardless of size, may disrupt the classic neural networks required for cognitive function. The investigators are currently collecting data to better characterize these difficulties and stroke patients' recovery as part of a previously approved recovery study. In this sub-study, the investigators propose to add MEG at 1 and 6 months in a subset of individuals with small: 1) subcortical, and 2) cortical lesions. The investigators will partner with colleagues at the University of Maryland (College Park), who are well experienced with MEG to conduct this research. In addition a control population of age-similar individuals will be recruited for comparison. Cerebral activation patterns of individuals with stroke versus controls will be compared, both across patients with stroke at a given time point, and within subjects from 1 to 6 months to determine the association of abnormal activation with cognitive dysfunction and recovery. \*\*The investigators have recently extended follow-up by adding an additional assessment at 12 months and will enroll additional participants (up to 40 patients with minor stroke, 15 age-similar controls).

Conditions

Stroke; Stroke Sequelae; Stroke/Brain Attack

Outcome Measures

Primary Outcomes (6)

• Cerebral Activity Measured Using Magnetoencephalography (MEG)

  Global patterns of cerebral activity as well as individual brain areas important for cognitive processing will be analyzed for differences with respect to amplitude, latency, and frequency.

  Up to 10 weeks

• Cerebral Activity Measured Using Magnetoencephalography (MEG)

  Global patterns of cerebral activity as well as individual brain areas important for cognitive processing will be analyzed for differences with respect to amplitude, latency, and frequency.

  Up to 6 months

• Cerebral Activity Measured Using Magnetoencephalography (MEG)

  Global patterns of cerebral activity as well as individual brain areas important for cognitive processing will be analyzed for differences with respect to amplitude, latency, and frequency.

  Up to 12 months

• Reaction Time

  Reaction times will be recorded and compared during the visual naming task

  Up to 10 weeks

• Reaction Time

  Reaction times will be recorded and compared during the visual naming task

  Up to 6 months

• Reaction Time

  Reaction times will be recorded and compared during the visual naming task

  Up to 12 months

Secondary Outcomes (3)

• MOCA

  Up to 10 weeks

• MOCA

  Up to 6 months

• MOCA

  Up to 12 months

Study Arms (2)

Minor Stroke

We will enroll a cohort of 15 adult patients previously admitted to Johns Hopkins Bayview Medical Center with small/minor acute ischemic stroke visible on neuroimaging. Patients will follow-up in clinic 4-6 weeks following hospital discharge. To be eligible for the study, patients must have a "minor stroke", defined as NIH Stroke Scale score at follow-up of less than or equal to 8, modified Rankin score of 0-2, be competent speakers of English, and have no prior history of stroke, dementia, or untreated psychiatric disease. Those with proximal large vessel (M1) or branch (M2) occlusions will be excluded. \*Based on preliminary results we have expanded our trial and will continue to recruit up to 40 patients with minor stroke.

Diagnostic Test: Magnetoencephalography (MEG)

Controls

For comparison, we will recruit a group of age-similar controls (n=15) without neurologic disease or prior clinical history of stroke.

Diagnostic Test: Magnetoencephalography (MEG)

Interventions

Magnetoencephalography (MEG) DIAGNOSTIC_TEST

Participants will undergo MEG at the University of Maryland (College Park) to measure cerebral activity while performing a visual naming task. The Montreal Cognitive Assessment (MOCA) will also be administered.

Also known as: Cognitive Testing

Controls; Minor Stroke

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from those recently hospitalized with minor stroke at Johns Hopkins Bayview Medical Center (see inclusion criteria). Controls will include friends, family, and other volunteers of similar age meeting Inclusion Criteria.

You may qualify if:

• Adults (≥18 years) admitted to Bayview Medical Center Neurology.
• Evidence of acute ischemic stroke (CT or MRI)- lacunar stroke or branch occlusion (M3/A3/P3 or smaller) OR NIHSS ≤ 8 on admission.
• Competent speaker of English (by self or family report) prior to stroke.
• Return for follow-up 4-6 weeks post event (+/- 4 wks).
• Cognitive deficits present on initial testing.\*\* unique to MEG study
• Willing to travel to the University of Maryland twice for MEG.\*\* unique to MEG study
• Fully independent functionally and able to travel to the University of Maryland unassisted.\*\* unique to MEG study

You may not qualify if:

• Primary intracerebral hemorrhage- as evidenced by blood on head CT or MRI.
• Previous neurological disease (e.g., dementia, multiple sclerosis, prior symptomatic stroke). Incidental asymptomatic lacunar strokes found on imaging will not be excluded as prior disease.
• Uncorrected hearing or visual loss.
• Large vessel occlusion.
• 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 in the eyes.\*\* unique to MEG study
• Claustrophobia, obesity, and/or any other reason leading to difficulty staying in the MEG for up to 1 hour.\*\* unique to MEG study
• For controls- clinical history of stroke or other neurological dysfunction (seizure, multiple sclerosis, etc.); psychiatric disease

Sponsors & Collaborators

• Johns Hopkins University: lead
• University of Maryland, College Park: collaborator
• American Heart Association: collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21210, United States

RECRUITING

Related Publications (4)

• Chen K, Marsh EB. Chronic post-stroke fatigue: It may no longer be about the stroke itself. Clin Neurol Neurosurg. 2018 Nov;174:192-197. doi: 10.1016/j.clineuro.2018.09.027. Epub 2018 Sep 17.

  PMID: 30266010 BACKGROUND

• Marsh EB, Lawrence E, Gottesman RF, Llinas RH. The NIH Stroke Scale Has Limited Utility in Accurate Daily Monitoring of Neurologic Status. Neurohospitalist. 2016 Jul;6(3):97-101. doi: 10.1177/1941874415619964. Epub 2015 Dec 13.

  PMID: 27366291 BACKGROUND

• 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.

  PMID: 29306185 BACKGROUND

• 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.

  PMID: 33318200 RESULT

Related Links

• Marsh Lab Website

MeSH Terms

Conditions

Stroke

Interventions

Magnetoencephalography

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Magnetometry; Investigative Techniques

Study Officials

• Elisabeth B Marsh, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabeth B Marsh, MD

CONTACT

410-550-8703; ebmarsh@jhmi.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 6, 2019
• Study Start: July 1, 2018
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Complete results will be published at the conclusion of the study, though initial results are published and available for review (final citation below).
• Access Criteria: Upon request. In addition, anonymized MEG fif files used for preliminary analysis and publication have been deposited in the University of Maryland Data Repositories. All other data pertaining to the published study are included in the article and Supporting Information (SI) Appendix.

Locations

US (1)