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StrokeNCT04188522

Imaging Post-Stroke Recovery: Using MEG to Evaluate Cognition

An observational study of Stroke and Stroke Sequelae, run by Johns Hopkins University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Stroke, Stroke Sequelae, Stroke/Brain Attack
What is being tested?
Magnetoencephalography (MEG)
How many people
55 participants
Where
1 siteUnited States
Study dates
1 Jul 2018to 30 Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Elisabeth B Marsh, MD contact

410-550-8703

ebmarsh@jhmi.edu

United States1 site, 1 recruiting
  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21210

    Elisabeth B Marsh, MD, 410-550-8703, ebmarsh@jhmi.edu

    Rafael H Llinas, MD, 410-550-1042, rllinas@jhmi.edu

    Recruiting

Other trials in United States

About this study

Official title: Imaging the Network: Using MEG to Determine the Pathophysiology Underlying Post-Stroke Cognitive Impairment

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).

Read the detailed description

This is a prospective longitudinal study of patients with minor stroke versus age-similar controls that will make use of the following protocol:

  • Patients are admitted to the hospital for acute stroke and undergo work-up including MRI; they are entered into a clinical outcomes database (routine clinical care)
  • All patients are scheduled for an appointment in the Bayview Stroke Intervention Clinic approximately 4-6 weeks +/- 4 weeks post-stroke
  • Seen at 4-6 weeks (routine care)- consented and tested if enrolled (per research protocol, as part of a prior approved study on stroke recovery)
  • Those meeting inclusion criteria for MEG testing will be consented and undergo the following additional procedures: 1 month MEG visit at the University of Maryland- brain activity will be measured at rest and during cognitive tasks evaluating domains such as: executive function, attention, and multi-tasking including a visual naming test Repeat MEG at approximately 6 months +/- 4 weeks post-stroke

University of Maryland's MEG Protocol:

The head shape will be measured using a 3D tracking system. This involves using a plastic stylus to mark a series of points around the head that will map the entire surface of the head. In addition, each of three "fiducial" points; one in front of each ear and one above and between the eyes will be marked. The purpose of the head shape measurement is to be able to co-localize brain activity recorded with the MEG with the subject's MRI.

Magnetic fields will be recorded using a 275-channel whole-head MEG system. A third-order gradient will be used for noise cancellation.

The MEG system non- invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic EEG signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The location may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain. MEG is also used to non-invasively locate regions of epileptic activity within the brain. The localization information provided by MEG may be used, in conjunction with other diagnostic data, in neurosurgical planning.

The total length of the MEG recordings will depend on the length of the tasks (an estimate of 30-45 min has been used). There will be a 2-5 -minute break between each run. For all runs magnetic fields will be recorded in 42 consecutive 10-second trials. In this way if there are artifacts during the session, such as the subject moving his or her head, the 10-second trial during which this occurs can be eliminated from analysis.

Patients will return for their 6 month and 12 month post-stroke follow-up appointments (routine care) and testing (if part of the recovery study).

Being tested
Magnetoencephalography (MEG)
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetoencephalography (MEG)Diagnostic test

    Also called Cognitive Testing

    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.

Study groups in NCT04188522
Study groupRoleWhat they receive
Minor StrokeWe 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.
Receives: Diagnostic Test: Magnetoencephalography (MEG)
ControlsFor comparison, we will recruit a group of age-similar controls (n=15) without neurologic disease or prior clinical history of stroke.
Receives: Diagnostic Test: Magnetoencephalography (MEG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 10 weeks

  2. 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.

    Measured: Up to 6 months

  3. 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.

    Measured: Up to 12 months

  4. Reaction Time

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

    Measured: Up to 10 weeks

  5. Reaction Time

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

    Measured: Up to 6 months

  6. Reaction Time

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

    Measured: Up to 12 months

Secondary outcomes (3)
  1. MOCA

    Scores on the MOCA will be compared between those with minor stroke and controls

    Measured: Up to 10 weeks

  2. MOCA

    Scores on the MOCA will be compared between those with minor stroke and controls

    Measured: Up to 6 months

  3. MOCA

    Scores on the MOCA will be compared between those with minor stroke and controls

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2019
  2. Study start1 Jul 2018
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04188522
Sponsor's protocol ID
IRB00122221
Other IDs
18IPA34170313
Status last verified
Jun 2026
First submitted
2 Dec 2019
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data will be available upon request of the PI. Otherwise, de-identified results will be reported in aggregate.

Publications

  • 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.

    PubMed 30266010
  • 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.

    PubMed 27366291
  • 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.

    PubMed 29306185
  • 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.

    PubMed 33318200

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Stroke Sequelae, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elisabeth B Marsh, MD (410-550-8703, ebmarsh@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cerebral Activity Measured Using Magnetoencephalography (MEG) (time frame: Up to 10 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04188522, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

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