NCT04188522 Imaging Post-Stroke Recovery: Using MEG to Evaluate Cognition
| NCT ID | NCT04188522 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 55 participants |
| Start Date | 2018-07-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 55 participants in total. It began in 2018-07-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Elisabeth B Marsh, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins School of Medicine
Frequently Asked Questions
Who can join the NCT04188522 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04188522 currently recruiting?
Yes, NCT04188522 is actively recruiting participants. Contact the research team at ebmarsh@jhmi.edu for enrollment information.
Where is the NCT04188522 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT04188522 clinical trial?
NCT04188522 is sponsored by Johns Hopkins University. The principal investigator is Elisabeth B Marsh, MD at Johns Hopkins School of Medicine. The trial plans to enroll 55 participants.
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