Adults 18 to 100, any sex, with Stroke or Stroke Sequelae. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Cognition as Assessed by the Montreal Cognitive Assessment ScorePrimary· 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.
1 month
Group
Value
95% CI
Mindfulness Based Stress Reduction (MBSR)
23.5
± 5.2
Stroke Support Group (SSG)
22.5
± 5.9
6 months
Group
Value
95% CI
Mindfulness Based Stress Reduction (MBSR)
25.5
± 3.7
Stroke Support Group (SSG)
23.7
± 6.0
Change in Cerebral Activity as Assessed by Functional Connectivity on Magnetoencephalography (MEG)Primary· 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.
1 month
Group
Value
95% CI
Mindfulness Based Stress Reduction (MBSR)
1.99
± 0.83
Stroke Support Group (SSG)
0
± 0
6 months
Group
Value
95% CI
Mindfulness Based Stress Reduction (MBSR)
2.19
± 0.90
Stroke Support Group (SSG)
0
± 0
Change in Quality of Life as Assessed by a Likert ScalePrimary· 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.
1 month
Group
Value
95% CI
Mindfulness Based Stress Reduction (MBSR)
5.7
± 2.2
Stroke Support Group (SSG)
6.1
± 1.1
6 months
Group
Value
95% CI
Mindfulness Based Stress Reduction (MBSR)
5.2
± 1.9
Stroke Support Group (SSG)
5.1
± 1.8
Change in Depression as Assessed by the Patient Health Questionnaire (PHQ-9)Primary· 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.
1 month
Group
Value
95% CI
Mindfulness Based Stress Reduction (MBSR)
6.7
± 7.3
Stroke Support Group (SSG)
5.2
± 5.9
6 months
Group
Value
95% CI
Mindfulness Based Stress Reduction (MBSR)
6.1
± 6.9
Stroke Support Group (SSG)
4.9
± 3.9
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
Last refreshed: 20 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04302493.