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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-13

Study Completion Date

2018-01-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Females

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

Group Type EXPERIMENTAL

Functional MRI scan

Intervention Type DEVICE

7.0 Tesla functional MRI scan

Males

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

Group Type EXPERIMENTAL

Functional MRI scan

Intervention Type DEVICE

7.0 Tesla functional MRI scan

Interventions

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Functional MRI scan

7.0 Tesla functional MRI scan

Intervention Type DEVICE

Eligibility Criteria

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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

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes