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

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Healthy

Treatments: Device: Functional MRI scan

Study type: Interventional

Funder types: Other

Identifiers

NCT02739646

NL54890.068.15

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 21 to 35 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Females

Experimental group

Description:

Functional MRI scan of the somatosensory cortex while the breast skin is stimulated by piezo-stimulators.

Treatment:

Device: Functional MRI scan

Males

Experimental group

Description:

Functional MRI scan of the somatosensory cortex while the breast skin is stimulated by piezo-stimulators.

Treatment:

Device: Functional MRI scan