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Touch and Attention MRI Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01432288
Recruitment Status : Completed
First Posted : September 12, 2011
Last Update Posted : August 10, 2017
Information provided by (Responsible Party):

September 8, 2011
September 12, 2011
August 10, 2017
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 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.
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
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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Wake Forest University Health Sciences ( Wake Forest University )
Wake Forest University
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Principal Investigator: Kathi Kemper, MD, MPH Wake Forest University Health Sciences
Wake Forest University Health Sciences
August 2017