Trial record 3 of 1512 for:    Peripheral Neuropathy

Effects of Meditation on Multiple Sclerosis and Peripheral Neuropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jinny Tavee, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00981643
First received: September 21, 2009
Last updated: September 7, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Multiple Sclerosis
Peripheral Neuropathy
Behavioral: Meditation instruction and practice

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Effects of Meditation on Pain, Fatigue and Physical Functioning in Patients With Multiple Sclerosis and Peripheral Neuropathy

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • To determine if meditation has a beneficial effect on pain, fatigue and physical functioning in patients with multiple sclerosis and peripheral neuropathy [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine, in the neuropathy arms, if there is an improvement seen on the neurological evaluation with regards to weakness and sensory changes with meditation [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2009
Study Completion Date: December 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multiple Sclerosis, Meditation group Behavioral: Meditation instruction and practice
Meditation techniques introduced and practiced, in a group setting, once weekly for 8 weeks
No Intervention: Multiple Sclerosis, Control group
Experimental: Peripheral Neuropathy, Meditation group Behavioral: Meditation instruction and practice
Meditation techniques introduced and practiced, in a group setting, once weekly for 8 weeks
No Intervention: Peripheral Neuropathy, Control group

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981643

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Jinny Tavee, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Jinny Tavee, Dr., The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00981643     History of Changes
Other Study ID Numbers: CCF 08-950
Study First Received: September 21, 2009
Last Updated: September 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Meditation
Multiple Sclerosis
Peripheral Neuropathy

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neuromuscular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 18, 2014