To study the neuroplasticity of the brain after mastectomy and breast reconstructive surgery by assessing the somatotopy of the breast on the somatosensory cortex of patients who underwent either breast reconstruction with and without nerveā¦
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Breast therapeutic procedures
Synonym
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
-
Background summary
To study the effects of mastectomy and autologous breast reconstruction on the
sensation of the (reconstructed) breast, not only the peripheral reinnervation
of the breast should be studied, but also the changes that take place in the
somatosensory cortex. The sensation of the reconstructed breast has been
studied previously, but the neuroplasticity of the brain, or the ability of the
brain to change after - in this case - breast surgery, remains unknown.
Recently, a pilot study with healthy subjects has been conducted to localize
the sensation of the breast on the somatosensory cortex using 7 Tesla
functional MRI imaging. Now that the region of interest in the brain and the
somatotopy of the non-operated breast are known, studies with patients who
underwent mastectomy and breast reconstruction are the next step to understand
the neuroplasticity of the brain following breast surgery.
Study objective
To study the neuroplasticity of the brain after mastectomy and breast
reconstructive surgery by assessing the somatotopy of the breast on the
somatosensory cortex of patients who underwent either breast reconstruction
with and without nerve restoration or mastectomy without breast reconstruction.
Study design
A single center imaging study carried out in MUMC+. Every subject will undergo
a single functional MRI scan in the 7 Tesla MRI scan of Scannexus at least six
months after the operation. A scanning session takes approximately 75 minutes.
During the scan, piezo-electric stimulators are applied to both the
reconstructed and non-operated breast in a fixed pattern. These stimulators
stimulate the skin and sensory nerves of the breast and nipple-areola complex
in a random sequence.
Study burden and risks
All subjects are recruited by their treating physicians at the outpatient
clinic of plastic surgery and surgical oncology or by means of a recruitment
letter on behalf of the treating physician. Patients are informed about the
study and the procedures, and the subject information and consent form are
handed out. If patients are willing to participate, an appointment is made with
the researcher to sign the consent form, fill out the CRF and schedule the MRI
scan. On a later moment every subject will undergo a single functional MRI scan
taking 75 minutes. There are no follow-up moments. Subjects do not have any
direct benefits in participating in the study. 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 stimulators 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 stimulators. No radiation is involved.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- Female over 18 years old
- Unilateral mastectomy without breast reconstruction
- Unilateral mastectomy with DIEP flap breast reconstruction (with or without
sensory nerve restoration)
- At least six months after initial surgery
- Informed consent
Exclusion criteria
- Bilateral mastectomy / breast reconstruction
- Active disease / metastasis
- Previous radiation therapy on the breast or axilla
- Diseases associated with neuropathy (e.g. diabetes mellitus)
- Previous brain surgery
- Previous allergic reactions to adhesives or plasters
- Any MRI exclusion criteria:
-- No piercings or other iron materials (except a metal brace behind front
teeth)
--Pacemaker/ICD, implanted pumps or stimulators
-- Claustrophobia
-- Epilepsy
-- Heart rhythm disorders
-- Pregnancy
-- Permanent make-up or tattoos in head and neck area
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 | NCT03702556 |
CCMO | NL67696.068.18 |