StrokeNCT04302493
Mindfulness Based Stress Reduction and Post-Stroke Cognition
A study testing Mindfulness Based Stress Reduction (MBSR) and Stroke Support Group (SSG) in people with Stroke and Stroke Sequelae, run by Johns Hopkins University at 1 site in United States.
Trial 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'… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke, Stroke Sequelae, Depression
- What is being tested?
- Mindfulness Based Stress Reduction (MBSR) and Stroke Support Group (SSG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Stroke Sequelae, Depression, Cognitive Impairment
- Being tested
- Mindfulness Based Stress Reduction (MBSR), Stroke Support Group (SSG)
- Medical subject headings
- Stroke, Depression, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress Reduction (MBSR)Behavioural
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.
Stroke Support Group (SSG)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) | Experimental | Participants randomized to the MBSR arm will undergo a standard 8 week course. Receives: Behavioral: Mindfulness Based Stress Reduction (MBSR) |
| Stroke Support Group (SSG) | Active comparator | As a control group, participants will participate in 8 weeks of weekly Stroke Support Group. Receives: Behavioral: Stroke Support Group (SSG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-intervention (1 months post-stroke) and post-intervention visit (6 months post-stroke)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Jan 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to an 8 week Mindfulness Based Stress Reduction (MBSR) course versus a traditional Stroke Support Group (SSG)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, College Park, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Elisabeth B Marsh, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302493
- Sponsor's protocol ID
- IRB00242665
- Status last verified
- Dec 2024
- First submitted
- 6 Mar 2020
- Last updated
- 20 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available upon request of the PI. Otherwise, de-identified results will be reported in aggregate.
Publications
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.
PubMed 30266010Marsh 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.
PubMed 29306185Marsh 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.
PubMed 27366291Girgenti 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.
PubMed 40933043
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Matters: The Impact of Mindfulness Based Stress Reduction on Post-Stroke Cognition
- ClinicalTrials.gov ID
- NCT04302493
- Acronym / sponsor ID
- IRB00242665
- Conditions
- Stroke, Stroke Sequelae, Depression, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of Maryland, College Park, National Institutes of Health (NIH)
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Posted 20 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized to an 8 week Mindfulness Based Stress Reduction (MBSR) course versus a traditional Stroke Support Group (SSG)
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) | Experimental | Behavioral: Mindfulness Based Stress Reduction (MBSR)Participants randomized to the MBSR arm will undergo a standard 8 week course. |
| Stroke Support Group (SSG) | Active comparator | Behavioral: Stroke Support Group (SSG)As a control group, participants will participate in 8 weeks of weekly Stroke Support Group. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Mindfulness Based Stress Reduction (MBSR) |
| 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. | Behavioural | Stroke Support Group (SSG) |
Primary outcome
Change in Cognition as Assessed by the Montreal Cognitive Assessment Score
Time frame: Pre-intervention (1 month post-stroke) and post-intervention visit (6 months post-stroke)
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 Functional Connectivity on Magnetoencephalography (MEG)
Time frame: Pre-intervention (1 month post-stroke) and post-intervention visit (6 months post-stroke)
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.
Change in Quality of Life as Assessed by a Likert Scale
Time frame: Pre-intervention (1 month post-stroke) and post-intervention visit (6 months post-stroke)
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.
Change in Depression as Assessed by the Patient Health Questionnaire (PHQ-9)
Time frame: Pre-intervention (1 months post-stroke) and post-intervention visit (6 months post-stroke)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30266010Chen 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.
- Background: PubMed 29306185Marsh 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.
- Background: PubMed 27366291Marsh 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 publication: PubMed 40933043Girgenti 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.
- Marsh Lab WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data will be available upon request of the PI. Otherwise, de-identified results will be reported in aggregate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth B Marsh, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction (MBSR) and Stroke Support Group (SSG) in people with Stroke and Stroke Sequelae, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognition as Assessed by the Montreal Cognitive Assessment Score (time frame: Pre-intervention (1 month post-stroke) and post-intervention visit (6 months post-stroke)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04302493, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024; AzTrials last refreshed its copy on 29 Oct 2026.