Imaging Post-Stroke Recovery: Using MEG to Evaluate Cognition

Sponsor
Johns Hopkins University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04188522
Collaborator
University of Maryland, College Park (Other), American Heart Association (Other)
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Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Magnetoencephalography (MEG)

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).

Study Design

Study Type:
Observational
Anticipated Enrollment :
55 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Imaging the Network: Using MEG to Determine the Pathophysiology Underlying Post-Stroke Cognitive Impairment
Actual Study Start Date :
Jul 1, 2018
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
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)
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.
Other Names:
  • Cognitive Testing
  • 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)
    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.
    Other Names:
  • Cognitive Testing
  • Outcome Measures

    Primary Outcome Measures

    1. Cerebral Activity Measured Using Magnetoencephalography (MEG) [Up to 10 weeks]

      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.

    2. Cerebral Activity Measured Using Magnetoencephalography (MEG) [Up to 6 months]

      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.

    3. Cerebral Activity Measured Using Magnetoencephalography (MEG) [Up to 12 months]

      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.

    4. Reaction Time [Up to 10 weeks]

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

    5. Reaction Time [Up to 6 months]

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

    6. Reaction Time [Up to 12 months]

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

    Secondary Outcome Measures

    1. MOCA [Up to 10 weeks]

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

    2. MOCA [Up to 6 months]

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

    3. MOCA [Up to 12 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    1. Adults (≥18 years) admitted to Bayview Medical Center Neurology.

    2. Evidence of acute ischemic stroke (CT or MRI)- lacunar stroke or branch occlusion (M3/A3/P3 or smaller) OR NIHSS ≤ 8 on admission.

    3. Competent speaker of English (by self or family report) prior to stroke.

    4. Return for follow-up 4-6 weeks post event (+/- 4 wks).

    5. Cognitive deficits present on initial testing.** unique to MEG study

    6. Willing to travel to the University of Maryland twice for MEG.** unique to MEG study

    7. Fully independent functionally and able to travel to the University of Maryland unassisted.** unique to MEG study

    Exclusion Criteria:
    1. Primary intracerebral hemorrhage- as evidenced by blood on head CT or MRI.

    2. 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.

    3. Uncorrected hearing or visual loss.

    4. Large vessel occlusion.

    5. 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

    6. Claustrophobia, obesity, and/or any other reason leading to difficulty staying in the MEG for up to 1 hour.** unique to MEG study

    7. For controls- clinical history of stroke or other neurological dysfunction (seizure, multiple sclerosis, etc.); psychiatric disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins Bayview Medical Center Baltimore Maryland United States 21210

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Elisabeth B Marsh, MD, Johns Hopkins School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT04188522
    Other Study ID Numbers:
    • IRB00122221
    • 18IPA34170313
    First Posted:
    Dec 6, 2019
    Last Update Posted:
    Jun 10, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 10, 2022