Imaging Post-Stroke Recovery: Using MEG to Evaluate Cognition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

White Matter Connections and Memory: the STRATEGIC Study

NCT03982147

Stroke Cognitive Impairment Memory Impairment

UNKNOWN

Microstructure Imaging in Stroke Patients

NCT04118790

Fatigue Stroke, Acute Transient Ischemic Attack

RECRUITING

MEG and DTI of Neural Function and Connectivity in Traumatic Brain Injury

NCT01298557

Traumatic Brain Injury Post-concussive Symptoms

COMPLETED

Correlation Between Cognition and Neuroimaging in TIA Patients

NCT04989608

Transient Ischemic Accident

RECRUITING NA

Non-Heme Iron Load Quantification in the Brain - MRI of Patients With Stroke

NCT01829386

Stroke

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Stroke Sequelae Stroke/Brain Attack

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Magnetoencephalography (MEG)

Intervention Type 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.

Controls

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

Magnetoencephalography (MEG)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cognitive Testing

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No