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Mindfulness Based Stress Reduction (MBSR) for Stroke

N/A

Waitlist Available

Led By Elisabeth B Marsh, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 and 6 months

Awards & highlights

Study Summary

This trial will test whether Mindfulness Based Stress Reduction (MBSR) can help improve cognitive function in people who have had a stroke. MBSR is a form of therapy that is already known to be effective in treating anxiety and depression related to frontal lobe dysfunction. This trial will use MEG (magnetoencephalography) to image brain activity and see if there are changes in the brain after treatment that correspond to improvements in cognitive function.

Eligible Conditions

Stroke
Depression
Cognitive Impairment

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 and 6-month visits

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 and 6-month visits

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 and 6-month visits for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Cerebral Activity as assessed by the amplitude on Magnetoencephalography (MEG)

Change in Cerebral Activity as assessed by the latency on MEG

Change in Cognition as assessed by the Montreal Cognitive Assessment score

+2 more

Secondary outcome measures

Ability to Return to Work as assessed by a yes/no questionnaire

Change in Cerebral Connectivity Patterns on MEG

Change in anxiety as assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) score

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mindfulness Based Stress Reduction (MBSR)Experimental Treatment1 Intervention

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

Group II: Stroke Support Group (SSG)Active Control1 Intervention

As a control group, participants will participate in 8 weeks of weekly Stroke Support Group.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindfulness Based Stress Reduction (MBSR)

2010

N/A

~760

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,260 Previous Clinical Trials

14,820,750 Total Patients Enrolled

33 Trials studying Stroke

28,892 Patients Enrolled for Stroke

University of Maryland, College ParkOTHER

155 Previous Clinical Trials

45,635 Total Patients Enrolled

5 Trials studying Stroke

284 Patients Enrolled for Stroke

Elisabeth B Marsh, MDPrincipal InvestigatorJohns Hopkins University

3 Previous Clinical Trials

115 Total Patients Enrolled

2 Trials studying Stroke

115 Patients Enrolled for Stroke

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participant count for this experiment?

"Affirmative. The clinicaltrials.gov records demonstrate that recruitment for this trial has been open since January 1st 2021 and was last modified on October 10th 2022. 40 individuals must be recruited from a single medical facility."

Answered by AI

Are participants aged 18 or older eligible for this research study?

"The researchers of this project are seeking participants aged 18 to 99."

Answered by AI

Is it possible to be a participant in this clinical experiment?

"The current recruitment phase of this study is open to 40 individuals between 18 and 100 with diagnosed depression. Furthermore, these patients must exhibit an NIHSS score lower than 8 at their initial follow-up visit (around 30 days post-stroke) as well as a mRS rating ranging from 0 to 2 during that same appointment."

Answered by AI

What beneficial effects are hoped to be gleaned from this experiment?

"This medical study, to be conducted over a 1 and 6-month period, seeks to measure changes in cognition as assessed by the Montreal Cognitive Assessment scale. Secondary objectives include gauging fatigue via PROMIS ratings, MEG patterns of cerebral connectivity through Granger Causality statistics during resting states and visual task completion, and depression levels using patient reported outcomes from pre-MBSR PROMIS scores."

Answered by AI

Is this experimental study still accepting participants?

"As per clinicaltrials.gov, the search for participants is still ongoing. This trial was originally advertised on January 1st 2021 and has undergone editing as recently as October 10th 2022."

Answered by AI

Recent research and studies

Clinical Neurology and NeurosurgeryJournal

Chronic Post-stroke Fatigue: It May No Longer Be About the Stroke Itself

Chen, Karen, and Elisabeth B. Marsh. 2018. “Chronic Post-stroke Fatigue: It May No Longer Be About the Stroke Itself”. Clinical Neurology and Neurosurgery. Elsevier BV. doi:10.1016/j.clineuro.2018.09.027.

The NeurohospitalistJournal

The NIH Stroke Scale Has Limited Utility in Accurate Daily Monitoring of Neurologic Status

Marsh, Elisabeth B., Erin Lawrence, Rebecca F. Gottesman, and Rafael H. Llinas. 2015. “The NIH Stroke Scale Has Limited Utility in Accurate Daily Monitoring of Neurologic Status”. The Neurohospitalist. SAGE Publications. doi:10.1177/1941874415619964.

Clinical Neurology and NeurosurgeryJournal

Pre-stroke Employment Results in Better Patient-reported Outcomes After Minor Stroke

Marsh, Elisabeth B., Erin Lawrence, Argye E. Hillis, Karen Chen, Rebecca F. Gottesman, and Rafael H. Llinas. 2018. “Pre-stroke Employment Results in Better Patient-reported Outcomes After Minor Stroke”. Clinical Neurology and Neurosurgery. Elsevier BV. doi:10.1016/j.clineuro.2017.12.020.

clinicaltrials.govStudy