Effects of Meditation on Multiple Sclerosis and Peripheral Neuropathy

NCT ID: NCT00981643

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-12-31

Brief 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.

Detailed 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.

Conditions

Multiple Sclerosis; Peripheral Neuropathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Multiple Sclerosis, Meditation group

Multiple Sclerosis, Meditation instruction and practice group

Group Type: EXPERIMENTAL

Meditation instruction and practice

Intervention Type: BEHAVIORAL

Meditation techniques introduced and practiced, in a group setting, once weekly for 8 weeks

Multiple Sclerosis, Control group

Multiple Sclerosis, Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Peripheral Neuropathy, Meditation group

Peripheral Neuropathy, Meditation instruction and practice group

Group Type: EXPERIMENTAL

Meditation instruction and practice

Intervention Type: BEHAVIORAL

Meditation techniques introduced and practiced, in a group setting, once weekly for 8 weeks

Peripheral Neuropathy, Control group

Peripheral Neuropathy, Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Meditation instruction and practice

Meditation techniques introduced and practiced, in a group setting, once weekly for 8 weeks

Intervention Type: BEHAVIORAL

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jinny Tavee, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CCF 08-950

Identifier Type: -

Identifier Source: org_study_id