Mindfulness Based Stress Reduction and Post-Stroke Cognition
Condition: Stroke; Stroke Sequelae; Depression; Cognitive Impairment
MeSH terms: Stroke
Study type: Interventional

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.
    

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.
    

Intervention name(s): Mindfulness Based Stress Reduction (MBSR); Stroke Support Group (SSG)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Primary purpose: Treatment