MEG Study of Mindfulness Based Stress Reduction

This study is currently recruiting participants.

Verified by National Center for Complementary and Alternative Medicine (NCCAM), August 2008

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00571051

Purpose

The purpose of this research is to investigate the effects of mindfulness based stress reduction (MBSR) on measures of brain function. We are looking especially at the ways in which MBSR may affect the way the brain processes the sense of touch. The study seeks to recruit healthy, normal adults who are interested in MBSR training, a simple program that involves learning how to pay attention mindfully to the present moment

Condition	Intervention
Somatosensory Cortical Dynamics in Normal Humans	Behavioral: Mindfulness Based Stress Reduction

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Outcomes Assessor), Historical Control, Parallel Assignment
Official Title:	MEG Study of Mindfulness Based Stress Reduction

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

Somatosensory cortical dynamics [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rumination; mindfulness; somatosensory evoked potentials; tactile thresholds [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	October 2007
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MBSR 8 week course	Behavioral: Mindfulness Based Stress Reduction 8 week course in mindfulness training
2: No Intervention 8 weeks of natural history

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

You are eligible to participate in this study because you meet all of our selection criteria:

You are between ages 18-50
You are right-handed
You are able to receive a MRI scan (you have no metal implants or other metal objects or medical devices that would make a MRI scan unsafe for you)
You are able to follow study instructions and can read and write English

Exclusion Criteria:

You are not eligible to participate in this study if you:
- have any systemic musculoskeletal diseases such as rheumatoid arthritis, systemic lupus, or scleroderma that would affect the function of your nervous system
- have any neurological conditions that might affect your hand, wrist, or arm function
- respond to our questionnaires in a manner suggesting you may be suffering from depression
- are pregnant or a nursing mother
- currently have any ongoing meditation practice, including MBSR.
- are unable to complete our study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571051

Contacts

Contact: Joel Villanueva, BS		joel_villanueva@hms.harvard.edu
Contact: Catherine Kerr, PhD	617-384-8583

Locations

United States, Massachusetts
Harvard Medical School	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Catherine Kerr, PhD 617-384-8583 catherine_kerr@hms.harvard.edu

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Catherine Kerr, PhD

Harvard University

More Information

Publications:

Kerr CE, Wasserman RH, Moore CI. Cortical dynamics as a therapeutic mechanism for touch healing. J Altern Complement Med. 2007 Jan-Feb;13(1):59-66. Review. Erratum in: J Altern Complement Med. 2007 Mar;13(2):301.

Responsible Party:	Harvard Medical School ( Catherine Kerr )
Study ID Numbers:	K01 AT003459, 001
Study First Received:	December 7, 2007
Last Updated:	August 11, 2008
ClinicalTrials.gov Identifier:	NCT00571051
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

MEG, mindfulness, tactile perception

Study placed in the following topic categories:

Stress

ClinicalTrials.gov processed this record on January 13, 2009