Clinical trial NCT04302493: Mindfulness Based Stress Reduction and Post-Stroke Cognition
Official title: Mindfulness Matters: The Impact of Mindfulness Based Stress Reduction on Post-Stroke Cognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Stroke Sequelae
Depression
Cognitive Impairment
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: University of Maryland, College Park
name: National Institutes of Health (NIH)
First posted: 2020-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to an 8 week Mindfulness Based Stress Reduction (MBSR) course versus a traditional Stroke Support Group (SSG)
Primary purpose: TREATMENT

Brief 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.

Detailed description: Thrombectomy has significantly improved stroke outcomes. Nearly 80% of the investigators' clinic population now present with small strokes and low NIH Stroke Scale (NIHSS) scores. However, despite "good recoveries", greater than 40% endorse significant problems with concentration, attention, executive function, processing speed, and mood during the subacute phase of recovery. This dysfunction prohibits individuals from fully reintegrating into the individuals' prior home and workplace environments and can result in early retirement or loss of independence, particularly in the older population. Some degree of recovery is observed by 6 months, but it is often incomplete or too late to reverse prior life-altering decisions. The impaired executive function and processing speed appear to occur independent of stroke size, location, or co-existing depression.

Magnetoencephalography (MEG) is a functional imaging tool able to evaluate neurophysiologic processes in real time similar to EEG, but with better spatial resolution. The investigators' prior work with MEG suggests that cerebral activation patterns are not only slowed and more dispersed during task completion in individuals with minor stroke compared to controls, but that there is abnormal activity in the frontal lobes, even at rest. Unfortunately, many patients do not qualify for rehabilitation and there is little data regarding effective treatment options to hasten or augment recovery.

Mindfulness training may provide an attractive therapeutic option. A combination of meditation, body awareness, and yoga, Mindfulness Based Stress Reduction (MBSR) is an active process thought to engage the frontal lobes. MBSR has been shown to improve anxiety and depression in patients with chronic disease states like migraine and diabetes, and has also been evaluated in a small series of patients with chronic stroke and traumatic brain injury demonstrating improved performance during tasks of executive function.

The investigators propose to study the effect of MBSR in the early phase of stroke recovery to determine if this intervention can help to prevent post-stroke morbidity. A cohort of patients \[NIHSS \<8, modified Rankin Scale (mRS) 0-2\] will be enrolled. Half will be randomized to a standard 8 week course of MBSR, while the control group will instead participate in a weekly Stroke Support Group (SSG). Depression, cognition, patient perception of recovery, and degree of re-integration into prior environments will be evaluated pre- and post-intervention to determine the impact of mindfulness training on subacute post-stroke depression and cognition. All participants will undergo neuroimaging using MEG pre- and post-intervention to determine the neurophysiologic effect of treatment.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
measure: 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)
measure: 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)
measure: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Elisabeth B Marsh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen K, Marsh EB. Chronic post-stroke fatigue: It may no longer be about the stroke itself. Clin Neurol Neurosurg. 2018 Nov;174:192-197. doi: 10.1016/j.clineuro.2018.09.027. Epub 2018 Sep 17.
citation: Marsh EB, Lawrence E, Hillis AE, Chen K, Gottesman RF, Llinas RH. Pre-stroke employment results in better patient-reported outcomes after minor stroke: Short title: Functional outcomes after minor stroke. Clin Neurol Neurosurg. 2018 Feb;165:38-42. doi: 10.1016/j.clineuro.2017.12.020. Epub 2017 Dec 27.
citation: Marsh EB, Lawrence E, Gottesman RF, Llinas RH. The NIH Stroke Scale Has Limited Utility in Accurate Daily Monitoring of Neurologic Status. Neurohospitalist. 2016 Jul;6(3):97-101. doi: 10.1177/1941874415619964. Epub 2015 Dec 13.
citation: Girgenti, S. G., Dallasta, I., Lawrence, E., Merbach, D., Simon, J. Z., Llinas, R. H., ... & Marsh, E. B. (2024). Modified-Mindfulness-Based Stress Reduction as a Treatment for Cognitive Recovery in Patients with Minor Stroke: a Randomized Controlled Pilot Study. medRxiv, 2024-11.