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 range18 Years – 100 Years

SexALL

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.

What they're measuring

Change in Cognition as Assessed by the Montreal Cognitive Assessment Score

Timeframe: Pre-intervention (1 month post-stroke) and post-intervention visit (6 months post-stroke)

Change in Cerebral Activity as Assessed by Functional Connectivity on Magnetoencephalography (MEG)

Timeframe: Pre-intervention (1 month post-stroke) and post-intervention visit (6 months post-stroke)

Change in Quality of Life as Assessed by a Likert Scale

Timeframe: Pre-intervention (1 month post-stroke) and post-intervention visit (6 months post-stroke)

Change in Depression as Assessed by the Patient Health Questionnaire (PHQ-9)

Timeframe: Pre-intervention (1 months post-stroke) and post-intervention visit (6 months post-stroke)

Trial details

NCT IDNCT04302493

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-01

Results submitted2024-11-27

View on ClinicalTrials.gov More Stroke trials

Plain-language summary

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Cognition as Assessed by the Montreal Cognitive Assessment Score

Timeframe: Pre-intervention (1 month post-stroke) and post-intervention visit (6 months post-stroke)

Change in Cerebral Activity as Assessed by Functional Connectivity on Magnetoencephalography (MEG)

Timeframe: Pre-intervention (1 month post-stroke) and post-intervention visit (6 months post-stroke)

Change in Quality of Life as Assessed by a Likert Scale

Timeframe: Pre-intervention (1 month post-stroke) and post-intervention visit (6 months post-stroke)

Change in Depression as Assessed by the Patient Health Questionnaire (PHQ-9)

Timeframe: Pre-intervention (1 months post-stroke) and post-intervention visit (6 months post-stroke)