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
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.
Studie Overzicht
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Limburg
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Maastricht, Limburg, Nederland, 6229 HX
- Maastricht University Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Females
Functional MRI scan of the somatosensory cortex while the breast skin is stimulated by piezo-stimulators.
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7.0 Tesla functional MRI scan
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Experimenteel: Males
Functional MRI scan of the somatosensory cortex while the breast skin is stimulated by piezo-stimulators.
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7.0 Tesla functional MRI scan
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Changes in the blood oxygen level dependent (BOLD) contrast as a function of vibrotactile stimulation of the breast and nipple-areola complex
Tijdsspanne: 90 minutes
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Changes will be analysed using multi-voxel pattern analysis to localize the different parts of the breast in the somatosensory cortex.
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90 minutes
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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
Tijdsspanne: 90 minutes
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Differences between both sexes in localization or representation of the breast in the somatosensory cortex will be assessed.
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90 minutes
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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
Tijdsspanne: 90 minutes
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Differences between individuals of the same sex in localization or representation of the breast in the somatosensory cortex will be assessed.
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90 minutes
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Rene van der Hulst, prof,MD,PhD, Maastricht University Hospital
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- NL54890.068.15
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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