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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01432288
Other study ID # WFUIRB00016834
Secondary ID
Status Completed
Phase N/A
First received September 8, 2011
Last updated August 8, 2017
Start date August 2011
Est. completion date December 2011

Study information

Verified date August 2017
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Center for Biomolecular Imaging and Center for Integrative Medicine, Wake Forest University Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

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