Exploring Advanced Imaging Techniques to Characterize Botulinum Toxin Diffusion in Human Muscle
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Exploring Advanced Imaging Techniques to Characterize Botulinum Toxin Diffusion|
- 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.
|Study Start Date:||March 2010|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Drug: Botox (botulinum toxin)
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.
|Contact: Grace Kim, OTR/Lfirstname.lastname@example.org|
|Contact: Jaclyn Nestor, BAemail@example.com|
|United States, New York|
|New York Presbyterian Hospital/Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10065|
|Contact: Grace Kim firstname.lastname@example.org|
|Principal Investigator: Michael W O'Dell, MD|
|Sub-Investigator: Jaclyn A Nestor, BA|
|Sub-Investigator: Keith D Hentel, MD|
|Sub-Investigator: Jonathan P Dyke, Ph.D.|
|Sub-Investigator: Douglas Ballon, Ph.D.|
|Sub-Investigator: Guarav Telhan, MD|
|Principal Investigator:||Michael W O'Dell, MD||Weill Medical College of Cornell University|