NCT01432288

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 10, 2017

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

September 8, 2011

Last Update Submit

August 8, 2017

Conditions

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Biomolecular Imaging and Center for Integrative Medicine, Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

  • Kathi Kemper, MD, MPH

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2011

First Posted

September 12, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

August 10, 2017

Record last verified: 2017-08

Locations