Exploring Advanced Imaging Techniques to Characterize Botulinum Toxin Diffusion in Human Muscle
Exploring Advanced Imaging Techniques to Characterize Botulinum Toxin Diffusion
調査の概要
詳細な説明
Over the past decade, botulinum toxins (BT) have been extensively used to treat any number of diverse disorders, including functionally significant, focal spasticity in the arm and leg of persons with injury/disease of the central nervous system. Spasticity is an involuntary muscle stiffness that limits movement of an extremity and often leads to pain, hygiene problems, difficulty in bed or wheelchair positioning, and functional deficits in self-care and mobility.
There are three BT products on the market: MyoBloc®, Botox®, and Dysport®. FDA approval for use of Botox® in spasticity is anticipated sometime during 2010. In the Weill Cornell Division of Rehabilitation Medicine alone, nearly 50,000 units of Botox® were injected for the treatment of spasticity during the 2008-2009 academic year. (Note: The vast majority of the BT market share in the US rests with Botox®.)
There is excellent evidence supporting the effectiveness of BT in decreasing tone and modest clinical evidence supporting functional improvement. Despite the frequent use, however, there is astonishingly little evidence delineating the impact on diffusion of dosing, dilution, approach to muscle localization, or serotype of BT. To better study these relationships we will be using advanced imaging to develop a model to characterize the physical characteristics of BT diffusion in human skeletal muscle.
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
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New York
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New York、New York、アメリカ、10065
- New York Presbyterian Hospital/Weill Cornell Medical College
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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:
- diagnosis of UMN disease
- clinically significant spasticity in the gastrocnemius muscle to warrant Botox® injection (made at the discretion of Dr. O'Dell)
- naïve to all botulinum toxins in the lower extremity
Exclusion Criteria:
- MR incompatibility with implanted ferromagnetic devices.[Specifically, they may not participate in this study if they have a pacemaker, an implanted defibrillator or certain other implanted electronic or metallic devices. They will be screened by the MRI staff for past surgical procedures to determine the possibility of having an implanted medical or metallic device, shrapnel, or other metal, such as metal in the eye.]
- Pregnancy or breast feeding
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：ヘルスサービス研究
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：botox diffusion
Each subject was given 3 injections in lateral gastrocnemius muscle:2 botox, 1 saline, each injection was 2.5mL.
MRI of the lower leg was taken prior to injections and 2 months post for a comparison of diffusion properties.
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A series of three injections will be made simultaneously to the gastroc-soleus muscles of the affected lower limb; this will be the only drug intervention/injection session throughout the study, and occurs at baseline.
The top injection site, closest to the knee, consists of 25 units of Botox and 0.25 cc saline.
The bottom injection site, closest to the ankle, also consists of 25 units of Botox and 0.25 cc saline.
The middle injection site will be considered the placebo injection, as it will not contain any Botox (0 units Botox) and 0.25 cc saline.
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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 |
|---|---|---|
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MRI
時間枠：Baseline (0 months), 2 months and 3 months
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Subjects will undergo non-contrast MRI's of the target leg prior to Botox injections (0 months), then again at both 2 months and 3 months following the Botox injections.
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Baseline (0 months), 2 months and 3 months
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協力者と研究者
捜査官
- 主任研究者：Michael W O'Dell, MD、Weill Medical College of Cornell University
出版物と役立つリンク
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 (見積もり)
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
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。
Botox (botulinum toxin)の臨床試験
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