N/A
N=30
Mindfulness Based Stress Reduction and Post-Stroke Cognition
Stroke · Stroke Sequelae · Depression · Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT04302493 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Change in Cognition as Assessed by the Montreal Cognitive Assessment Score — 23.5; 22.5; 25.5; 23.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness Based Stress Reduction (MBSR) (Behavioral); Stroke Support Group (SSG) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cognition as Assessed by the Montreal Cognitive Assessment Score |
23.5; 22.5; 25.5; 23.7 | — |
| PRIMARY Change in Cerebral Activity as Assessed by Functional Connectivity on Magnetoencephalography (MEG) |
1.99; 0; 2.19; 0 | — |
| PRIMARY Change in Quality of Life as Assessed by a Likert Scale |
5.7; 6.1; 5.2; 5.1 | — |
| PRIMARY Change in Depression as Assessed by the Patient Health Questionnaire (PHQ-9) |
6.7; 5.2; 6.1; 4.9 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04302493). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.