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Completed

NCT Number: NCT02739646

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

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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Key information

Conditions

Age range

21 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Functional MRI scan

Device

7.0 Tesla functional MRI scan

Primary outcomes

  1. Changes in the blood oxygen level dependent (BOLD) contrast as a function of vibrotactile stimulation of the breast and nipple-areola complex

    Time frame: 90 minutes

    Changes will be analysed using multi-voxel pattern analysis to localize the different parts of the breast in the somatosensory cortex.

Secondary outcomes

  1. 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

    Time frame: 90 minutes

    Differences between both sexes in localization or representation of the breast in the somatosensory cortex will be assessed.

  2. 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

    Time frame: 90 minutes

    Differences between individuals of the same sex in localization or representation of the breast in the somatosensory cortex will be assessed.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Maastricht University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 15, 2016
Registry last updated
Feb 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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