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.
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Limburg
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Maastricht, Limburg, Nederland, 6229 HX
- Maastricht University Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
Tidsramme: 90 minutes
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Differences between both sexes in localization or representation of the breast in the somatosensory cortex will be assessed.
|
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
Tidsramme: 90 minutes
|
Differences between individuals of the same sex in localization or representation of the breast in the somatosensory cortex will be assessed.
|
90 minutes
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Rene van der Hulst, prof,MD,PhD, Maastricht University Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- NL54890.068.15
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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