Exploring Advanced Imaging Techniques to Characterize Botulinum Toxin Diffusion in Human Muscle
Exploring Advanced Imaging Techniques to Characterize Botulinum Toxin Diffusion
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New York
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New York, New York, 미국, 10065
- New York Presbyterian Hospital/Weill Cornell Medical College
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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MRI
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Michael W O'Dell, MD, Weill Medical College of Cornell University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
뇌졸중에 대한 임상 시험
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Institut National de la Santé Et de la Recherche...모병
Botox (botulinum toxin)에 대한 임상 시험
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Merz Pharmaceuticals GmbH완전한
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Daewoong Pharmaceutical Co. LTD.아직 모집하지 않음
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JHM BioPharma (Tonghua) Co. , Ltd.모병