Mindfulness Based Stress Reduction and Post-Stroke Cognition

June 5, 2023 updated by: Johns Hopkins University

Mindfulness Matters: The Impact of Mindfulness Based Stress Reduction on Post-Stroke Cognition

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness Based Stress Reduction (MBSR)
Participants randomized to the MBSR arm will undergo a standard 8 week course.
Behavioral: Mindfulness Based Stress Reduction (MBSR)
Participants randomized to the MBSR arm will undergo a standard 8 week course of MBSR taught by a psychologist trained in the MBSR protocol and encouraged to engage in additional individual mindfulness sessions using a cell phone application.
Active Comparator: Stroke Support Group (SSG)
As a control group, participants will participate in 8 weeks of weekly Stroke Support Group.
Behavioral: Stroke Support Group (SSG)
As a control group, participants randomized to the SSG arm will participate in 8 weeks of weekly Stroke Support Group sessions to experience activity and socialization without additional mindfulness training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cognition as assessed by the Montreal Cognitive Assessment score
Time Frame: At 1 and 6-month visits
The Montreal Cognitive Assessment (MoCA) tests executive function, attention, concentration, memory, and processing speed. The MoCA is scored on a scale of 0-30. Scores of less than 26 are considered abnormal.
At 1 and 6-month visits
Change in Cerebral Activity as assessed by the amplitude on Magnetoencephalography (MEG)
Time Frame: At 1 and 6-month visits
Participants will undergo an MEG evaluating the amplitude of evoked potentials: 1) during resting state, and 2) during completion of a visual task.
At 1 and 6-month visits
Change in Cerebral Activity as assessed by the latency on MEG
Time Frame: At 1 and 6-month visits
Participants will undergo an MEG evaluating the latency of evoked potentials: 1) during resting state, and 2) during completion of a visual task.
At 1 and 6-month visits
Change in Quality of Life as assessed by a Likert scale
Time Frame: At 1 and 6-month visits
Patient-reported assessment of quality of life (Likert scale 1-7) at the 1 and 6 month visits.
At 1 and 6-month visits
Change in Depression as assessed by the Patient Health Questionnaire (PHQ-9)
Time Frame: At 1 and 6-month visits
The PHQ-9 will be administered to participants to evaluate for post-stroke depression. The PHQ-9 is scored on a scale of 0-27 with scores of 5-9 being indicative of mild depression and higher scores more severe depression.
At 1 and 6-month visits

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in anxiety as assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) score
Time Frame: At 1 and 6 months
A subset of the PROMIS measures will also be administered pre- and post-MBSR to evaluate patient-reported outcomes within the MBSR group. Higher scores indicate more anxiety.
At 1 and 6 months
Change in depression as assessed by the PROMIS score
Time Frame: At 1 and 6 months
A subset of the PROMIS measures will also be administered pre- and post-MBSR to evaluate patient-reported outcomes within the MBSR group. Higher scores indicate more depression.
At 1 and 6 months
Change in fatigue as assessed by the PROMIS score
Time Frame: At 1 and 6 months
A subset of the PROMIS measures will also be administered pre- and post-MBSR to evaluate patient-reported outcomes within the MBSR group. Higher scores indicate more fatigue.
At 1 and 6 months
Change in Cerebral Connectivity Patterns on MEG
Time Frame: At 1 and 6-month visits
Participants will undergo an MEG evaluating cerebral activity and connectivity patterns using Granger Causality statistics: 1) during resting state, and 2) during completion of a visual task.
At 1 and 6-month visits
Ability to Return to Work as assessed by a yes/no questionnaire
Time Frame: 1-month visit
The ability to return to work will be assessed (yes/no) at 1 month clinic visit.
1-month visit
Ability to Return to Work as assessed by a yes/no questionnaire
Time Frame: 6-month visit
The ability to return to work will be assessed (yes/no) at 6 months clinic visit.
6-month visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

University of Maryland, College Park

Investigators

  • Principal Investigator: Elisabeth B Marsh, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

March 6, 2020

First Submitted That Met QC Criteria

March 6, 2020

First Posted (Actual)

March 10, 2020

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00242665

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data will be available upon request of the PI. Otherwise, de-identified results will be reported in aggregate.

IPD Sharing Time Frame

Results will be published at the conclusion of the study.

IPD Sharing Access Criteria

Upon request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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