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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: Functional MRI scan


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 |