Multiple Sclerosis Clinical Trial

LoveYourBrain Yoga for Multiple Sclerosis

Summary

The purpose of the study is to assess the feasibility of a 6-week yoga and meditation intervention for people with multiple sclerosis (MS). The study will evaluate the impact of the program on fatigue, anxiety, depression, positive affect, and other measures. A sub-study will collect brain images using MRI on 2 subjects before and after the intervention to identify potential biological markers of MS related-fatigue.

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Full Description

This study will recruit 20 subjects with multiple sclerosis (MS) to participate in a 6-week yoga/meditation program. Subjects will be randomly assigned to one of two groups. The first group will complete the yoga/meditation classes, followed by a waiting period. The second group will go through a waiting period, followed by yoga/meditation classes. Two subjects assigned to classes during the first session will be selected to participate in an MRI sub-study to look for biomarkers of MS-associated fatigue. All subjects will complete questionnaires and assessments during 3 clinic visits - at baseline, in between the class sessions, and at the end of the study. Questionnaires will also be mailed to subjects 6 weeks after the last study visit.

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Eligibility Criteria

Inclusion Criteria:

Diagnosis of Multiple Sclerosis with EDSS score equal to or less than 6 (within last year)
18 years of age or older
Ability to ambulate without assistance from a device or person
Subjects taking medications for depression, fatigue, or anxiety must be stable for 8 weeks prior to baseline
Able to read, write, and speak English
Willing to refrain from participating in yoga or meditation outside of the study for the duration of enrollment
Willing and able to give informed consent

Exclusion Criteria:

Participation in yoga and/or meditation more than twice within 8 weeks prior to baseline.
MS symptom exacerbation in the 8 weeks before baseline or other serious medical conditions that would impair ability to participate in the study.
Any other reason that, in the investigator's opinion, would exclude the subject from participation in the study.
Contraindication to scanning, including but not limited to ferromagnetic metal in the body, claustrophobia, inability to lie still or otherwise tolerate being in the scanner.
Pregnant women must be excluded from the imaging component of the study due to unknown but possible risk of fetal exposure to the scanner. Women of child-bearing potential will take a confidential pregnancy test immediately prior to each scan session.

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

15

Study ID:

NCT03827928

Recruitment Status:

Completed

Sponsor:

Dartmouth-Hitchcock Medical Center

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There is 1 Location for this study

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Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

15

Study ID:

NCT03827928

Recruitment Status:

Completed

Sponsor:


Dartmouth-Hitchcock Medical Center

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