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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02739646
• Other study ID #: NL54890.068.15
• Status: Completed
• Phase: N/A
• First received: April 6, 2016
• Last updated: February 5, 2018
• Start date: July 13, 2016
• Est. completion date: January 17, 2018

Study information

• Verified date: February 2018
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 17, 2018
• Est. primary completion date: January 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Functional MRI scan
7.0 Tesla functional MRI scan

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the blood oxygen level dependent (BOLD) contrast as a function of vibrotactile stimulation of the breast and nipple-areola complex	Changes will be analysed using multi-voxel pattern analysis to localize the different parts of the breast in the somatosensory cortex.	90 minutes
Secondary	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	Differences between both sexes in localization or representation of the breast in the somatosensory cortex will be assessed.	90 minutes
Secondary	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	Differences between individuals of the same sex in localization or representation of the breast in the somatosensory cortex will be assessed.	90 minutes