To determine the exact localization of the representation of the sensibility of the breast and nipple-areola complex on the somatosensory cortex, in order to select a region of interest for upcoming studies. Secondly, to assess whether there are…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Niet van toepassing, onderzoek bij gezonde proefpersonen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
The temporo-spatial brain activity patterns are studied, to assess whether
there are differences in representation of the breast on the somatosensory
cortex between subjects of the same sex, as well as whether there are
sex-specific differences in representation.
Background summary
To explore the effects of mastectomy and autologous breast reconstructions, in
which neurorrhaphy or nerve anastomosis has been performed, on the sensibility
of the breast, the representation of the breast on the somatosensory cortex
should be studied. This has not been done in previous studies. Before the
aforementioned effects can be assessed in terms of neuroplasticity, the
representation of the breast must be precisely located with the use of a 7
Tesla fMRI. Therefore, a pilot study with healthy subjects is needed to
localize the sensibility of the breast on the somatosensory cortex.
Study objective
To determine the exact localization of the representation of the sensibility of
the breast and nipple-areola complex on the somatosensory cortex, in order to
select a region of interest for upcoming studies. 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 MUMC+.
Study burden and risks
All subjects have one appointment at the outpatient clinic for a short (10-15
minutes) introductory visit. Extra information about the study and procedures
is given, as well as the subject information and consent form. On a later
moment every subject will undergo 90 minutes of fMRI scanning. There are no
follow-up moments. In addition, there are no risks associated with
participation, except for the MRI-related risks like vertigo, nausea, an
anxious/claustrophobic feeling, and experiencing a taste of metal in the mouth
upon entering the scanner. In fMRI is no radiation involved. Subjects do not
have any benefits in participating in the study, except for the experience of
brain mapping. In the rare case an anomaly is identified on any of the fMRI
images, this will be discussed with the subject and this information is shared
with the general practitioner. Subjects who are willing to participate in the
study, accept the fact that vibrators are applied on a bare breast to stimulate
the skin and nipple-areola complex. The burden associated with participation in
this study, involves the usual MRI side effects (e.g. anxious or claustrophobic
feelings) and a possible adverse skin reaction to adhesives upon applying the
vibrators.
P. Debyelaan 25
Maastricht 6229HX
NL
P. Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
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.:
o (No piercings or other iron materials (except a metal brace behind front teeth)
o Claustrophobia)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02739646 |
| CCMO | NL54890.068.15 |