Exploring Advanced Imaging Techniques to Characterize Botulinum Toxin Diffusion in Human Muscle

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Grace Kim, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01412008
First received: August 4, 2011
Last updated: September 27, 2013
Last verified: September 2013

August 4, 2011
September 27, 2013
March 2010
June 2012   (final data collection date for primary outcome measure)
MRI [ Time Frame: Baseline (0 months), 2 months and 3 months ] [ Designated as safety issue: No ]
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.
MRI (determining if advanced imaging (MRI) is the optimal method to visually characterize the diffusion of Botox ® in human skeletal muscle) [ Time Frame: Baseline up to 3 months ] [ Designated as safety issue: No ]
Anywhere from 2 to 4 non-contrast MRIs of the lower limb will be conducted, depending on relevance of data after the first 2 scans.
Complete list of historical versions of study NCT01412008 on ClinicalTrials.gov Archive Site
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Exploring Advanced Imaging Techniques to Characterize Botulinum Toxin Diffusion in Human Muscle
Exploring Advanced Imaging Techniques to Characterize Botulinum Toxin Diffusion

Since the use of botulinum toxin in treating spasticity has already been proven effective, we are now using magnetic resonance imaging to examine the toxin diffusion within muscle (post injection) in order to determine the specific toxin dose required for an optimal treatment response.

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.

Interventional
Not Provided
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Stroke
  • Muscle Spasticity
Drug: Botox (botulinum toxin)
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.
No Intervention: 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.
Intervention: Drug: Botox (botulinum toxin)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01412008
1002010863
No
Grace Kim, Weill Medical College of Cornell University
New York Presbyterian Hospital
Not Provided
Principal Investigator: Michael W O'Dell, MD Weill Medical College of Cornell University
New York Presbyterian Hospital
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP