Multiple Sclerosis Clinical Trial

Effects of Meditation on Multiple Sclerosis and Peripheral Neuropathy

Summary

This study will evaluate the effects of mindfulness and concentration meditation on pain, fatigue, and physical functioning in patients with either multiple sclerosis or peripheral neuropathy.

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Full Description

We propose a prospective, randomized controlled study evaluating the effects of mindfulness meditation and concentration meditation on pain, fatigue, and physical functioning in patients with either multiple sclerosis MS or a generalized polyneuropathy (PN). A secondary endpoint for the MS arm will include spasticity and for the PN arm will be the physical examination findings of sensory changes and weakness. Meditation classes of 90 minutes duration will be led by a Buddhist monk with over 20 years experience in meditation. Sessions will be held once weekly over a 3-month period. There will be an initial introduction session that will last approximately 180 minutes for the adminsitration of formal instructions and a training session on how to do the meditation. Outcome assessments will be answered electronically on a secure system or in written form that will be able to be completed at home or at the site of the meditation class. The data will be directly downloaded into a queriable database. Outcome assessments will be based on the Short Form (SF)-36 health survey and Visual Analog Scale (VAS) for pain at baseline and at 3 months. Additionally, the Neuropathy Impairment Score (NIS) will be used for the PN pts. The PDDS spasticity questionnaire and the fatigue portion of the MSQLI for fatigue will be used for the MS patients. We plan to recruit adult patients with either MS or PN through the current patient population in the Mellen Center and Neuromuscular Center and flyers placed throughout the Cleveland Clinic. Patients will be excluded if they have performed meditation within the last 6 months, are cognitively impaired, or have an underlying illness that would preclude comprehension of the instructions. Other exclusion criteria include a history of symptomatic cardiopulmonary disease, uncontrolled HTN, current alcohol or drug abuse, and kidney or renal failure. Patients must be ambulatory and able to toilet themselves.

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Eligibility Criteria

Inclusion Criteria:

Diagnosis of multiple sclerosis OR peripheral neuropathy

Exclusion Criteria:

Unable to walk without the assistance of others
Unable to toilet independently
Currently abusing drugs or alcohol
Have performed meditation within the last 6 months
Cognitive impairment or an underlying illness which would prevent the comprehension of instructions
History of symptomatic/unstable heart or lung disease
Uncontrolled high blood pressure
Kidney or renal failure

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

40

Study ID:

NCT00981643

Recruitment Status:

Completed

Sponsor:

The Cleveland Clinic

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There is 1 Location for this study

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Cleveland Clinic
Cleveland Ohio, 44195, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

40

Study ID:

NCT00981643

Recruitment Status:

Completed

Sponsor:


The Cleveland Clinic

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