The Representation of the Sensibility of the Breast on the Somatosensory Cortex

The Representation of the Sensibility of the Breast on the Somatosensory Cortex Using 7 Tesla fMRI: A Pilot Study

Rationale: The representation of the breast on the somatosensory cortex has not been precisely located. Therefore, a pilot study with healthy subjects is needed to localize the sensibility of the breast on the somatosensory cortex with the use of a 7 Tesla fMRI.

Objective: To determine the exact localization of the representation of the sensibility of the breast and nipple-areola complex on the somatosensory cortex. Secondly, to assess whether there are differences in representation between individuals of the same sex and between both sexes.

Study design: A single center pilot study carried out in the Maastricht University Medical Center, the Netherlands.

Study population: A total of 10 female and 10 male healthy individuals will be recruited.

Intervention: Every subject will undergo a functional MRI scan with stimulators applied to the bare breast in a fixed pattern. These stimulate the skin and sensory nerves of the breast and nipple-areola complex in a random sequence.

Main study parameters: The hemodynamic response after stimulation of the skin of the breast and nipple-areola complex, representing neuronal activity in that region, is measured. Within the somatosensory cortex (S1 and S2), the temporo-spatial brain activity patterns after the various stimulation conditions are assessed, and the representation of the breast on the somatosensory cortex is mapped.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Functional MRI scan

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Man or woman
• Between 21 and 35 years old
• Healthy; i.e. no comorbidities
• Women: breast size cup B or C
• BMI < 27.0 kg/m2
• Informed consent

Exclusion Criteria:

• Any comorbidities
• Previous breast operation of any kind
• Previous allergic reactions to adhesives or plasters
• Any MRI exclusion criteria e.g.:

(No piercings or other iron materials (except a metal brace behind front teeth) (Claustrophobia)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Females; Functional MRI scan of the somatosensory cortex while the breast skin is stimulated by piezo-stimulators.	Device: Functional MRI scan; 7.0 Tesla functional MRI scan
Experimental: Males; Functional MRI scan of the somatosensory cortex while the breast skin is stimulated by piezo-stimulators.	Device: Functional MRI scan; 7.0 Tesla functional MRI scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the blood oxygen level dependent (BOLD) contrast as a function of vibrotactile stimulation of the breast and nipple-areola complex	Changes will be analysed using multi-voxel pattern analysis to localize the different parts of the breast in the somatosensory cortex.	90 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the blood oxygen level dependent (BOLD) contrast as a function of vibrotactile stimulation of the breast and nipple-areola complex in males compared to females	Differences between both sexes in localization or representation of the breast in the somatosensory cortex will be assessed.	90 minutes
Changes in the blood oxygen level dependent (BOLD) contrast as a function of vibrotactile stimulation of the breast and nipple-areola complex between individuals of the same sex	Differences between individuals of the same sex in localization or representation of the breast in the somatosensory cortex will be assessed.	90 minutes

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Maastricht University
• Investigators: Principal Investigator: Rene van der Hulst, prof,MD,PhD, Maastricht University Hospital

Study record dates

Study Major Dates

• Study Start: July 13, 2016
• Primary Completion (Actual): January 17, 2018
• Study Completion (Actual): January 17, 2018

Study Registration Dates

• First Submitted: April 6, 2016
• First Submitted That Met QC Criteria: April 14, 2016
• First Posted (Estimate): April 15, 2016

Study Record Updates

• Last Update Posted (Actual): February 6, 2018
• Last Update Submitted That Met QC Criteria: February 5, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: NL54890.068.15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED