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LoveYourBrain Yoga for Multiple Sclerosis

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Dartmouth Health

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Behavioral: Yoga/meditation

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Diagnosis of Multiple Sclerosis with EDSS score equal to or less than 6 (within last year)
  2. 18 years of age or older
  3. Ability to ambulate without assistance from a device or person
  4. Subjects taking medications for depression, fatigue, or anxiety must be stable for 8 weeks prior to baseline
  5. Able to read, write, and speak English
  6. Willing to refrain from participating in yoga or meditation outside of the study for the duration of enrollment
  7. Willing and able to give informed consent

Exclusion criteria

  1. Participation in yoga and/or meditation more than twice within 8 weeks prior to baseline.
  2. MS symptom exacerbation in the 8 weeks before baseline or other serious medical conditions that would impair ability to participate in the study.
  3. Any other reason that, in the investigator's opinion, would exclude the subject from participation in the study.
  4. 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.
  5. 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

15 participants in 2 patient groups

Yoga/meditation
Experimental group
Description:
A 6-week yoga/meditation intervention.
Treatment:
Behavioral: Yoga/meditation
Wait list
No Intervention group
Description:
A wait list control period.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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