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Effects of Meditation on Multiple Sclerosis and Peripheral Neuropathy

Primary Purpose

Multiple Sclerosis, Peripheral Neuropathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meditation instruction and practice
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring Meditation, Multiple Sclerosis, Peripheral Neuropathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Multiple Sclerosis, Meditation group

Multiple Sclerosis, Control group

Peripheral Neuropathy, Meditation group

Peripheral Neuropathy, Control group

Arm Description

Multiple Sclerosis, Meditation instruction and practice group

Multiple Sclerosis, Control group

Peripheral Neuropathy, Meditation instruction and practice group

Peripheral Neuropathy, Control group

Outcomes

Primary Outcome Measures

Does meditation have a beneficial effect on pain, fatigue and physical functioning in patients with multiple sclerosis and peripheral neuropathy

Secondary Outcome Measures

Does meditation lead to improvements in the neurological evaluation with regards to weakness and sensory changes with meditation.

Full Information

First Posted
September 21, 2009
Last Updated
February 28, 2017
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00981643
Brief Title
Effects of Meditation on Multiple Sclerosis and Peripheral Neuropathy
Official Title
The Effects of Meditation on Pain, Fatigue and Physical Functioning in Patients With Multiple Sclerosis and Peripheral Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Peripheral Neuropathy
Keywords
Meditation, Multiple Sclerosis, Peripheral Neuropathy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multiple Sclerosis, Meditation group
Arm Type
Experimental
Arm Description
Multiple Sclerosis, Meditation instruction and practice group
Arm Title
Multiple Sclerosis, Control group
Arm Type
No Intervention
Arm Description
Multiple Sclerosis, Control group
Arm Title
Peripheral Neuropathy, Meditation group
Arm Type
Experimental
Arm Description
Peripheral Neuropathy, Meditation instruction and practice group
Arm Title
Peripheral Neuropathy, Control group
Arm Type
No Intervention
Arm Description
Peripheral Neuropathy, Control group
Intervention Type
Behavioral
Intervention Name(s)
Meditation instruction and practice
Intervention Description
Meditation techniques introduced and practiced, in a group setting, once weekly for 8 weeks
Primary Outcome Measure Information:
Title
Does meditation have a beneficial effect on pain, fatigue and physical functioning in patients with multiple sclerosis and peripheral neuropathy
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Does meditation lead to improvements in the neurological evaluation with regards to weakness and sensory changes with meditation.
Time Frame
2 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinny Tavee, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Meditation on Multiple Sclerosis and Peripheral Neuropathy

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