HealthyNCT02739646
The Representation of the Sensibility of the Breast on the Somatosensory Cortex
A study testing Functional MRI scan in people with Healthy, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Functional MRI scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Jul 2016to 17 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX
About this study
Official title: 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.
Read more
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.
- Conditions
- Healthy
- Being tested
- Functional MRI scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional MRI scanDevice
7.0 Tesla functional MRI scan
| Study group | Role | What they receive |
|---|---|---|
| Females | Experimental | Functional MRI scan of the somatosensory cortex while the breast skin is stimulated by piezo-stimulators. Receives: Device: Functional MRI scan |
| Males | Experimental | Functional MRI scan of the somatosensory cortex while the breast skin is stimulated by piezo-stimulators. Receives: Device: Functional MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the blood oxygen level dependent (BOLD) contrast as a function of vibrotactile stimulation of the breast and nipple-areola complex
Changes will be analysed using multi-voxel pattern analysis to localize the different parts of the breast in the somatosensory cortex.
Measured: 90 minutes
Secondary outcomes (2)
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
Differences between both sexes in localization or representation of the breast in the somatosensory cortex will be assessed.
Measured: 90 minutes
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
Differences between individuals of the same sex in localization or representation of the breast in the somatosensory cortex will be assessed.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study start13 Jul 2016
- Primary completion17 Jan 2018
- Study completion17 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Principal investigator, Rene van der Hulst, Maastricht University Medical Center
- Investigators
- Rene van der Hulst, prof,MD,PhD, Principal investigator, Maastricht University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739646
- Sponsor's protocol ID
- NL54890.068.15
- Status last verified
- Feb 2018
- First submitted
- 6 Apr 2016
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Representation of the Sensibility of the Breast on the Somatosensory Cortex Using 7 Tesla fMRI: A Pilot Study
- ClinicalTrials.gov ID
- NCT02739646
- Acronym / sponsor ID
- NL54890.068.15
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- 13 Jul 2016
- Primary completion
- 17 Jan 2018 (actual)
- Study completion
- 17 Jan 2018 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Females | Experimental | Device: Functional MRI scanFunctional MRI scan of the somatosensory cortex while the breast skin is stimulated by piezo-stimulators. |
| Males | Experimental | Device: Functional MRI scanFunctional MRI scan of the somatosensory cortex while the breast skin is stimulated by piezo-stimulators. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional MRI scan7.0 Tesla functional MRI scan | Device | Females, Males |
Primary outcome
Changes in the blood oxygen level dependent (BOLD) contrast as a function of vibrotactile stimulation of the breast and nipple-areola complex
Time frame: 90 minutes
Changes will be analysed using multi-voxel pattern analysis to localize the different parts of the breast in the somatosensory cortex.
2 secondary outcomes
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
Time frame: 90 minutes
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
Time frame: 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rene van der Hulst, prof,MD,PhD principal investigator
Maastricht University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional MRI scan in people with Healthy, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the blood oxygen level dependent (BOLD) contrast as a function of vibrotactile stimulation of the breast and nipple-areola complex (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2018.