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CompletedNCT01432288Updated Aug 10, 2017

Touch and Attention MRI Study

An observational study in Central Nervous System, sponsored by Wake Forest University. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-10.

Sponsored by Wake Forest University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
10
Ages
18 Years to 40 Years
Sex
All
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Study 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.

Read the detailed 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.

02

Conditions studied

  • Central Nervous System
03

In context

Lead sponsor

Wake Forest University is the lead sponsor of 116 studies on the registry; 7 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 27 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
10 participants (actual)
06

Study locations

1 site
  • Center for Biomolecular Imaging and Center for Integrative Medicine, Wake Forest University
    Winston-Salem, North Carolina 27157, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01432288
Lead sponsor
Wake Forest University
Responsible party
Sponsor
First posted
Sep 12, 2011
Start date
Aug 2011
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Aug 10, 2017

Study contacts

Kathi Kemper, MD, MPH
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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