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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00379210
Other study ID # R21AT002761-01A1
Secondary ID R21AT002761-01A1
Status Completed
Phase N/A
First received September 20, 2006
Last updated December 20, 2011
Start date September 2006
Est. completion date August 2009

Study information

Verified date November 2007
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine behavioral and neural changes resulting from Mindfulness Meditation Training (MMT), and to use this knowledge in advancing our understanding of the mechanisms of attention.


Description:

Mindfulness Meditation Training (MMT) has been used successfully to decrease stress, pain, and adverse health symptoms in a varied subject population. MMT has been described as "paying attention in a particular way." Although attention is a key component of meditation, little is known about the cognitive and neural changes within the human attention system that result from MMT. In this study, we examine the effects of MMT on the human attention system using neurobehavioral measures. Here MMT comprises participation in a Mindfulness-Based-Stress-Reduction (MBSR) course, while the comparison group participates in a nutrition education course, both 8 weeks long. We compare the performance and neural activity of these groups both before and after participation in the course.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Men and women (all races and ethnicities) between 18 and 40 years old

- Women of childbearing age with a negative pregnancy test within 48 hours of scanning

- In good health

- Right-handed

- Normal or corrected-to-normal vision

- English as a first language

- Able to understand and provide signed informed consent

- No history of metal in their body or other reasons why they could not undergo an Magnetic Resonance Imaging

- No history of ischemic or hemorrhagic stroke, encephalopathy or encephalitis, minimal-cognitive impairment or dementia, movement disorder such as Parkinson's disease, head trauma causing loss of consciousness, cancer involving the central nervous system

Exclusion Criteria:

- Pregnant or breast-feeding women

- Individuals with implanted metal or electronic devices that would prevent them from MRI scanning.

- Individuals with a history of neurologic dysfunction that would prevent performance on attentional tasks including: history of transient ischemic attacks, history of cerebral infarction, history of Binswanger's disease (or a history of hypertensive encephalopathy), history of intracranial hemorrhage, history of head trauma with loss of consciousness, history of encephalitis, history of extended exposure to any known neurotoxin, history of acquired cognitive impairment, history of normal pressure hydrocephalus, history of a cancer metastatic to the central nervous system, history of Parkinson's or other basal ganglia disease, history of Guillain-Barré syndrome or chronic or relapsing polyneuropathy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms

  • Focus is Neural Effects of Mindfulness Training on Attention
  • No Condition

Intervention

Behavioral:
Mindfulness Meditation Training (MMT)
8-week training course in mindfulness meditation
Nutrition Education course
8-week course in nutrition

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reaction Times on the Sustained Attention to Response Task. Single digits (0-9) are flashed on the screen one by one. The number 3 is the target and all other digits are non-targets. The participant is asked to press the space bar for nontargets and withhold from pressing the space bar for the target. 9 weeks No
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