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Touch and Attention MRI Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kathi J. Kemper, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01432288
First received: September 8, 2011
Last updated: March 9, 2012
Last verified: March 2012

September 8, 2011
March 9, 2012
August 2011
December 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01432288 on ClinicalTrials.gov Archive Site
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Touch and Attention MRI Study
Effects of Touch and Attention on Central Nervous System Resting State Network (RSN) Activity

This study will measure resting state network central nervous system activity by functional magnetic resonance imaging (fMRI) during 4 separate interactions with a clinician. 1.

Hypothesis 1. Because they are different sensory systems, there will be different patterns of Mirror Neuron System (MNS)and Resting State Network (RSN) Central Nervous System (CNS) activity for visual vs. tactile stimulation, regardless of Loving Kindness Meditation (LKM).

Hypothesis 2. Because of unconscious, non-verbal signals, such as the practitioner's facial expression and respiratory rate, subjects' patterns of MNS and RSN CNS activity will differ for LKM+ vs. LKM- stimulation for both visual and tactile interventions.

Hypothesis 3. Because there is greater opportunity to detect signals from two sensory systems than one, the differences between CNS MNS and RSN activity patterns for LKM+ and LKM- will be greater for combined visual + tactile than for either visual or tactile stimulation alone.

This project builds on our previous research to build a platform for a successful NIH proposal to address a key gap in our understanding of the mechanism of non-verbal clinician-patient communication on physiology and behavior. Social neuroscience is a rapidly growing area of research that offers unique opportunities to better understand the mechanisms underlying common observations about clinician-patient interactions.The purpose of this study is to better understand the CNS mechanisms underlying the observed changes in self-reported well-being and ANS activity by evaluating resting fMRI activity under controlled conditions. The specific aims are to compare resting fMRI activity in the mirror neuron system (MNS) and resting state networks (RSN), reflected specifically in the Insula, Anterior Cingulate Cortex (ACC), Precuneus, Posterior Cingulate Cortex (PCC), Amygdala, Bilateral Inferior Parietal Cortex, Primary Motor-Visual System, and Dorsal Medulla while viewing touch with lovingkindness meditation lovingkindness meditation vs no lovingkindness meditation, receiving touch with lovingkindness meditation vs no lovingkindness meditation and both viewing and receiving touch with lovingkindness meditation vs no lovingkindness meditation. This is a descriptive study to generate sample size estimates for an NIH RO1 proposal.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample

Participants will be healthy individuals, 18< 40 years old, and can understand and respond to verbal directions while in an fMRI. Individuals over the age of 40 are excluded to provide a more homogeneous sample, to make this sample comparable to other research conducted at this institution and to decrease abnormalities in the outcome measures due to age-related changes.

Central Nervous System
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18-40 years old
  • healthy
  • can understand and respond to verbal directions while in an MRI

Exclusion Criteria:

  • blind
  • undergone treatment for brain tumor, stroke, intracranial hemorrhage
  • diabetes or any other form of peripheral neuropathy
  • require a pacemaker, insulin pump or other electronic equipment
  • taking beta blocking medications, systemic steroid medications or other medications likely to affect autonomic or central nervous system function
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01432288
WFUIRB00016834
Yes
Kathi J. Kemper, Wake Forest University
Wake Forest School of Medicine
Not Provided
Principal Investigator: Kathi Kemper, MD, MPH Wake Forest School of Medicine
Wake Forest School of Medicine
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP