Mindfulness Based Stress Reduction and Post-Stroke Cognition (NCT04302493) | Clinical Trial Compass
CompletedNot Applicable
Mindfulness Based Stress Reduction and Post-Stroke Cognition
United States30 participantsStarted 2021-01-01
Plain-language summary
The investigators don't fully understand how, regardless of the size or location in the brain, minor strokes can result in significant problems with focus, attention, and multi-tasking that prevent individuals from returning to an active lifestyle, and negatively impact quality of life; but the investigators' preliminary data using magnetoencephalography (MEG) suggest that there may be disruption of the neuronal network and abnormal frontal lobe activity in the brain after stroke. Mindfulness Based Stress Reduction (MBSR) is effective at treating frontal lobe dysfunction in the form of anxiety and depression occurring during the chronic phase of stroke recovery. The aim of this study is to use MBSR to improve other forms of frontal lobe dysfunction (cognitive outcomes) during the subacute phase of recovery, when patients are making critical decisions regarding patients' ability to return to work or live independently; and to use MEG, a tool capable of imaging brain activity and neuronal networks, to understand the brain changes that correspond to improvement after treatment.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults (≥18 years) presenting with neurological symptoms due to acute ischemic stroke (symptom onset within the week prior to admission).
* Evidence on brain MRI of acute ischemic stroke (imaging negative strokes and transient ischemic attacks (TIAs) will be excluded).
* Native English speaker (by self-report) prior to stroke.
* NIHSS \<8 at initial follow-up visit (approximately 30 days post-stroke).
* mRS 0-2 at initial follow-up visit.
Exclusion Criteria:
* Primary intracerebral hemorrhage- as evidenced by blood on head CT or MRI.
* Presence of proximal large vessel occlusion.
* Cortical exam findings including aphasia or neglect.
* Prior history of dementia or undertreated psychiatric illness.
* Uncorrected hearing or visual loss.
* Inability to attend weekly MBSR or Stroke Support Group sessions.
* Inability to travel to College Park (UMD) for 2 MEG recording sessions.
* 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 implants in the eyes (unlikely given that all patients will have an MRI and criteria are similar).
* Claustrophobia, obesity, and/or any other reason leading to difficulty staying in the MEG machine for up to 1 hour.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Cognition as Assessed by the Montreal Cognitive Assessment Score