Mindfulness Based Stress Reduction and Post-Stroke Cognition

NCT04302493 | Completed Results

• 1 other identifier: IRB00242665
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Stroke Sequelae; Depression; Cognitive Impairment

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (2)

Mindfulness Based Stress Reduction (MBSR)

EXPERIMENTAL

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

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.

Behavioral: Stroke Support Group (SSG)

Interventions

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.

Mindfulness Based Stress Reduction (MBSR)

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.

Stroke Support Group (SSG)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• University of Maryland, College Park: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (4)

• 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.

  PMID: 30266010 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.

  PMID: 29306185 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.

  PMID: 27366291 BACKGROUND

• 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.

  PMID: 40933043 RESULT

Related Links

• Marsh Lab Website

MeSH Terms

Conditions

Stroke; Depression; Cognitive Dysfunction

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

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.

Results Point of Contact

• Title: Elisabeth B. Marsh, MD
• Organization: Johns Hopkins School of Medicine

ebmarsh@jhmi.edu

410-550-8703

Study Officials

• Elisabeth B Marsh, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to an 8 week Mindfulness Based Stress Reduction (MBSR) course versus a traditional Stroke Support Group (SSG)

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 10, 2020
• Study Start: January 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: December 20, 2024
• Results First Posted: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Results will be published at the conclusion of the study.
• Access Criteria: Upon request

Locations

US (1)