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

NCT02739646 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-02-06

No results posted yet for this study

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

  • Healthy

Interventions

DEVICE

Functional MRI scan

7.0 Tesla functional MRI scan

Sponsors & Collaborators

  • Maastricht University

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Rene van der Hulst, prof,MD,PhD · Maastricht University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-13
Primary Completion
2018-01-17
Completion
2018-01-17

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02739646 on ClinicalTrials.gov