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Mindfulness Based Stress Reduction and Post-Stroke Cognition

Primary Purpose

Stroke, Stroke Sequelae, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction (MBSR)
Stroke Support Group (SSG)
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness Based Stress Reduction (MBSR)

Stroke Support Group (SSG)

Arm Description

Participants randomized to the MBSR arm will undergo a standard 8 week course.

As a control group, participants will participate in 8 weeks of weekly Stroke Support Group.

Outcomes

Primary Outcome Measures

Change in Cognition as assessed by the Montreal Cognitive Assessment score
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.
Change in Cerebral Activity as assessed by the amplitude on Magnetoencephalography (MEG)
Participants will undergo an MEG evaluating the amplitude of evoked potentials: 1) during resting state, and 2) during completion of a visual task.
Change in Cerebral Activity as assessed by the latency on MEG
Participants will undergo an MEG evaluating the latency of evoked potentials: 1) during resting state, and 2) during completion of a visual task.
Change in Quality of Life as assessed by a Likert scale
Patient-reported assessment of quality of life (Likert scale 1-7) at the 1 and 6 month visits.
Change in Depression as assessed by the Patient Health Questionnaire (PHQ-9)
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.

Secondary Outcome Measures

Change in anxiety as assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) score
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.
Change in depression as assessed by the PROMIS score
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.
Change in fatigue as assessed by the PROMIS score
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.
Change in Cerebral Connectivity Patterns on MEG
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.
Ability to Return to Work as assessed by a yes/no questionnaire
The ability to return to work will be assessed (yes/no) at 1 month clinic visit.
Ability to Return to Work as assessed by a yes/no questionnaire
The ability to return to work will be assessed (yes/no) at 6 months clinic visit.

Full Information

First Posted
March 6, 2020
Last Updated
June 5, 2023
Sponsor
Johns Hopkins University
Collaborators
University of Maryland, College Park
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1. Study Identification

Unique Protocol Identification Number
NCT04302493
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
University of Maryland, College Park

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke Sequelae, Depression, Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to an 8 week Mindfulness Based Stress Reduction (MBSR) course versus a traditional Stroke Support Group (SSG)
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Based Stress Reduction (MBSR)
Arm Type
Experimental
Arm Description
Participants randomized to the MBSR arm will undergo a standard 8 week course.
Arm Title
Stroke Support Group (SSG)
Arm Type
Active Comparator
Arm Description
As a control group, participants will participate in 8 weeks of weekly Stroke Support Group.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Stress Reduction (MBSR)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stroke Support Group (SSG)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Cognition as assessed by the Montreal Cognitive Assessment score
Description
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.
Time Frame
At 1 and 6-month visits
Title
Change in Cerebral Activity as assessed by the amplitude on Magnetoencephalography (MEG)
Description
Participants will undergo an MEG evaluating the amplitude of evoked potentials: 1) during resting state, and 2) during completion of a visual task.
Time Frame
At 1 and 6-month visits
Title
Change in Cerebral Activity as assessed by the latency on MEG
Description
Participants will undergo an MEG evaluating the latency of evoked potentials: 1) during resting state, and 2) during completion of a visual task.
Time Frame
At 1 and 6-month visits
Title
Change in Quality of Life as assessed by a Likert scale
Description
Patient-reported assessment of quality of life (Likert scale 1-7) at the 1 and 6 month visits.
Time Frame
At 1 and 6-month visits
Title
Change in Depression as assessed by the Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
At 1 and 6-month visits
Secondary Outcome Measure Information:
Title
Change in anxiety as assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) score
Description
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.
Time Frame
At 1 and 6 months
Title
Change in depression as assessed by the PROMIS score
Description
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.
Time Frame
At 1 and 6 months
Title
Change in fatigue as assessed by the PROMIS score
Description
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.
Time Frame
At 1 and 6 months
Title
Change in Cerebral Connectivity Patterns on MEG
Description
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.
Time Frame
At 1 and 6-month visits
Title
Ability to Return to Work as assessed by a yes/no questionnaire
Description
The ability to return to work will be assessed (yes/no) at 1 month clinic visit.
Time Frame
1-month visit
Title
Ability to Return to Work as assessed by a yes/no questionnaire
Description
The ability to return to work will be assessed (yes/no) at 6 months clinic visit.
Time Frame
6-month visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth B Marsh, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
30266010
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.
Results Reference
background
PubMed Identifier
29306185
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.
Results Reference
background
PubMed Identifier
27366291
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.
Results Reference
background
Links:
URL
http://marshlab.org
Description
Marsh Lab Website

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Mindfulness Based Stress Reduction and Post-Stroke Cognition

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