Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21210, United States
Location status: Recruiting
Location contact
Elisabeth B Marsh, MD
CONTACT
Rafael H Llinas, MD
CONTACT
NCT Number: NCT04188522
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).
Interested in participating?
Request Info18 year–100 year
All sexes
Observational
Baltimore, Maryland, 21210, United States
Location status: Recruiting
Elisabeth B Marsh, MD
CONTACT
Rafael H Llinas, MD
CONTACT
This is a prospective longitudinal study of patients with minor stroke versus age-similar controls that will make use of the following protocol:
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).
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 10 weeks
Reaction times will be recorded and compared during the visual naming task
Time frame: Up to 6 months
Reaction times will be recorded and compared during the visual naming task
Time frame: Up to 12 months
Reaction times will be recorded and compared during the visual naming task
Time frame: Up to 10 weeks
Scores on the MOCA will be compared between those with minor stroke and controls
Time frame: Up to 6 months
Scores on the MOCA will be compared between those with minor stroke and controls
Time frame: Up to 12 months
Scores on the MOCA will be compared between those with minor stroke and controls
Contact information is provided by the study sponsor or research team.
Johns Hopkins University
Other
Imaging the Network: Using MEG to Determine the Pathophysiology Underlying Post-Stroke Cognitive Impairment
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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