NCT02739646

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

July 13, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2018

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

1.5 years

First QC Date

April 6, 2016

Last Update Submit

February 5, 2018

Conditions

Healthy

Outcome Measures

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

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

    90 minutes

Secondary Outcomes (2)

  • 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

    90 minutes

  • 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

    90 minutes

Study Arms (2)

Females

EXPERIMENTAL

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

Device: Functional MRI scan

Males

EXPERIMENTAL

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

Device: Functional MRI scan

Interventions

Functional MRI scanDEVICE

7.0 Tesla functional MRI scan

FemalesMales

Eligibility Criteria

Age21 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 HX, Netherlands

Location

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Rene van der Hulst, prof,MD,PhD

    Maastricht University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

April 6, 2016

First Posted

April 15, 2016

Study Start

July 13, 2016

Primary Completion

January 17, 2018

Study Completion

January 17, 2018

Last Updated

February 6, 2018

Record last verified: 2018-02

Locations

NL(1)