Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04188522
Study type Observational
Source Johns Hopkins University
Contact Elisabeth B Marsh, MD
Phone 410-550-8703
Email ebmarsh@jhmi.edu
Status Recruiting
Phase
Start date July 1, 2018
Completion date June 30, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Suspended NCT03869138 - Alternative Therapies for Improving Physical Function in Individuals With Stroke N/A
Completed NCT04034069 - Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial N/A
Completed NCT04101695 - Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects N/A
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Recruiting NCT06204744 - Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial N/A
Active, not recruiting NCT06043167 - Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
Enrolling by invitation NCT04535479 - Dry Needling for Spasticity in Stroke N/A
Completed NCT03985761 - Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke N/A
Recruiting NCT00859885 - International PFO Consortium N/A
Recruiting NCT06034119 - Effects of Voluntary Adjustments During Walking in Participants Post-stroke N/A
Completed NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT05854485 - Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke N/A
Active, not recruiting NCT05520528 - Impact of Group Participation on Adults With Aphasia N/A
Active, not recruiting NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT05805748 - Serious Game Therapy in Neglect Patients N/A
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Recruiting NCT05993221 - Deconstructing Post Stroke Hemiparesis