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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Limburg
-
Maastricht、Limburg、オランダ、6229 HX
- Maastricht University Medical Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:他の
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Females
Functional MRI scan of the somatosensory cortex while the breast skin is stimulated by piezo-stimulators.
|
7.0 Tesla functional MRI scan
|
実験的:Males
Functional MRI scan of the somatosensory cortex while the breast skin is stimulated by piezo-stimulators.
|
7.0 Tesla functional MRI scan
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Changes in the blood oxygen level dependent (BOLD) contrast as a function of vibrotactile stimulation of the breast and nipple-areola complex
時間枠:90 minutes
|
Changes will be analysed using multi-voxel pattern analysis to localize the different parts of the breast in the somatosensory cortex.
|
90 minutes
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
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
時間枠:90 minutes
|
Differences between both sexes in localization or representation of the breast in the somatosensory cortex will be assessed.
|
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
時間枠: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
|
協力者と研究者
捜査官
- 主任研究者:Rene van der Hulst, prof,MD,PhD、Maastricht University Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- NL54890.068.15
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Functional MRI scanの臨床試験
-
Centre hospitalier de l'Université de Montréal...Allergan募集
-
Washington University School of MedicineMerck Sharp & Dohme LLC完了