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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Limburg
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Maastricht, Limburg, Pays-Bas, 6229 HX
- Maastricht University Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Rene van der Hulst, prof,MD,PhD, Maastricht University Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- NL54890.068.15
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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