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| Name | Class |
|---|---|
| University of Maryland, College Park | OTHER |
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) | Experimental | Participants randomized to the MBSR arm will undergo a standard 8 week course. |
|
| Stroke Support Group (SSG) | Active Comparator | As a control group, participants will participate in 8 weeks of weekly Stroke Support Group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) | Participants will undergo an MEG evaluating functional connectivity during resting state. GC links within the ipsilesional FPC were determined and differences in link count is reported below. | 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 | Patient-reported assessment of quality of life (Likert scale 1-7 with 7 being a better QOL) at the 1 and 6 month visits. Mean of participant choice is reported. | 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) | 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. | Pre-intervention (1 months post-stroke) and post-intervention visit (6 months post-stroke) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth B Marsh, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30266010 | Background | 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. | |
| 29306185 | Background | 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. |
| Label | URL |
|---|---|
| Marsh Lab Website | View source |
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Individual participant data will be available upon request of the PI. Otherwise, de-identified results will be reported in aggregate.
Results will be published at the conclusion of the study.
Upon request
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness Based Stress Reduction (MBSR) | Participants randomized to the MBSR arm will undergo a standard 8 week course. 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. |
| FG001 | Stroke Support Group (SSG) | As a control group, participants will participate in 8 weeks of weekly Stroke Support Group. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness Based Stress Reduction (MBSR) | Participants randomized to the MBSR arm will undergo a standard 8 week course. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention (1 month post-stroke) and post-intervention visit (6 months post-stroke) |
|
Up to 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness Based Stress Reduction (MBSR) | Participants randomized to the MBSR arm will undergo a standard 8 week course. 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. |
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9 participants either did not complete the second MEG visit or had technical difficulties, resulting in only 21 pairs of pre- and post-MEG data available for analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elisabeth B. Marsh, MD | Johns Hopkins School of Medicine | 410-550-8703 | ebmarsh@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2020 | Nov 27, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D003863 | Depression |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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Patients will be randomized to an 8 week Mindfulness Based Stress Reduction (MBSR) course versus a traditional Stroke Support Group (SSG)
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|
| Stroke Support Group (SSG) | Behavioral | 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. |
|
| 27366291 | Background | 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. |
| 40933043 | Result | Girgenti SG, Dallasta I, Lawrence E, Merbach D, Simon JZ, Llinas RH, Gould NF, Marsh EB. Modified-mindfulness-based stress reduction as a treatment for cognitive recovery in patients with minor stroke: a randomized controlled pilot study. Front Neurol. 2025 Aug 26;16:1534480. doi: 10.3389/fneur.2025.1534480. eCollection 2025. |
| BG001 | Stroke Support Group (SSG) | As a control group, participants will participate in 8 weeks of weekly Stroke Support Group. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Education | Mean | Standard Deviation | years |
|
| OG001 |
| Stroke Support Group (SSG) |
As a control group, participants will participate in 8 weeks of weekly Stroke Support Group. 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. |
|
|
| Primary | Change in Cerebral Activity as Assessed by Functional Connectivity on Magnetoencephalography (MEG) | Participants will undergo an MEG evaluating functional connectivity during resting state. GC links within the ipsilesional FPC were determined and differences in link count is reported below. | 21 patients returned and successfully completed their follow-up MEG leaving 21 pairs of MEG data for analysis of this outcome. | Posted | Mean | Standard Error | GC links | Pre-intervention (1 month post-stroke) and post-intervention visit (6 months post-stroke) |
|
|
|
| Primary | Change in Quality of Life as Assessed by a Likert Scale | Patient-reported assessment of quality of life (Likert scale 1-7 with 7 being a better QOL) at the 1 and 6 month visits. Mean of participant choice is reported. | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention (1 month post-stroke) and post-intervention visit (6 months post-stroke) |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-intervention (1 months post-stroke) and post-intervention visit (6 months post-stroke) |
|
|
|
| 1 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Stroke Support Group (SSG) | As a control group, participants will participate in 8 weeks of weekly Stroke Support Group. 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. | 0 | 14 | 0 | 14 | 0 | 14 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D004191 |
| Behavioral Disciplines and Activities |