Clinical Trials Directory

Trials / Completed

CompletedNCT02739646

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Maastricht University Medical Center · Academic / Other
Sex
All
Age
21 Years – 35 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEFunctional MRI scan7.0 Tesla functional MRI scan

Timeline

Start date
2016-07-13
Primary completion
2018-01-17
Completion
2018-01-17
First posted
2016-04-15
Last updated
2018-02-06

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT02739646. Inclusion in this directory is not an endorsement.