Healthy
Conditions
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.
Interventions
DEVICEFunctional MRI scan
7.0 Tesla functional MRI scan
Sponsors
Maastricht University
Maastricht University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the blood oxygen level dependent (BOLD) contrast as a function of vibrotactile stimulation of the breast and nipple-areola complex | 90 minutes | Changes will be analysed using multi-voxel pattern analysis to localize the different parts of the breast in the somatosensory cortex. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 90 minutes | Differences between both sexes in localization or representation of the breast in the somatosensory cortex will be assessed. |
| 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 | 90 minutes | Differences between individuals of the same sex in localization or representation of the breast in the somatosensory cortex will be assessed. |
Countries
Netherlands
Outcome results
None listed