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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Functional MRI scan

• Registration Number: NCT02739646
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-06
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-15
• Study Start: 2016-07-13
• Primary Completion: 2018-01-17
• Study Completion: 2018-01-17
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-05
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Females	Functional MRI scan	Functional MRI scan of the somatosensory cortex while the breast skin is stimulated by piezo-stimulators.
Males	Functional MRI scan	Functional MRI scan of the somatosensory cortex while the breast skin is stimulated by piezo-stimulators.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands