Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT04188522

Conditions

Stroke

Stroke Sequelae

Stroke/Brain Attack

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Magnetoencephalography (MEG)

Study Details

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

Study ID

NCT04188522

Start date

Jul 1, 2018

Status verified date

Jun, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not 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

Study Design

Enrollment

55 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Controls

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

Interventions

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.

Primary outcome measure

  • Cerebral Activity Measured Using Magnetoencephalography (MEG) [ Time Frame: Up to 10 weeks ]
  • Cerebral Activity Measured Using Magnetoencephalography (MEG) [ Time Frame: Up to 6 months ]
  • Cerebral Activity Measured Using Magnetoencephalography (MEG) [ Time Frame: Up to 12 months ]
  • Reaction Time [ Time Frame: Up to 10 weeks ]
  • Reaction Time [ Time Frame: Up to 6 months ]
  • Reaction Time [ Time Frame: Up to 12 months ]

Central Contacts and Locations

Central contacts

Elisabeth B Marsh, MD

410-550-8703ebmarsh@jhmi.edu

Locations

Johns Hopkins Bayview Medical Center

Recruiting

Baltimore, Maryland, United States, 21210

Contacts

Elisabeth B Marsh, MD

410-550-8703ebmarsh@jhmi.edu

Rafael H Llinas, MD

410-550-1042rllinas@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-06-05.