Effects of Meditation on Multiple Sclerosis and Peripheral Neuropathy
This study has been completed.
Sponsor:
The Cleveland Clinic
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
| Tracking Information | |||||
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| First Received Date ICMJE | September 21, 2009 | ||||
| Last Updated Date | September 7, 2011 | ||||
| Start Date ICMJE | February 2009 | ||||
| Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00981643 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Meditation on Multiple Sclerosis and Peripheral Neuropathy | ||||
| Official Title ICMJE | The Effects of Meditation on Pain, Fatigue and Physical Functioning in Patients With Multiple Sclerosis and Peripheral Neuropathy | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Meditation instruction and practice
Meditation techniques introduced and practiced, in a group setting, once weekly for 8 weeks |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00981643 | ||||
| Other Study ID Numbers ICMJE | CCF 08-950 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jinny Tavee, The Cleveland Clinic | ||||
| Study Sponsor ICMJE | The Cleveland Clinic | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | The Cleveland Clinic | ||||
| Verification Date | September 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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