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
  Purpose

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.


Condition Intervention
Stroke
Muscle Spasticity
Drug: Botox (botulinum toxin)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by New York Presbyterian Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 5
Study Start Date: March 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412008

Locations
United States, New York
New York Presbyterian Hospital/Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
New York Presbyterian Hospital
Investigators
Principal Investigator: Michael W O'Dell, MD Weill Medical College of Cornell University
  More Information

Additional Information:
No publications provided

Responsible Party: Grace Kim, Principal Investigator, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01412008     History of Changes
Other Study ID Numbers: 1002010863
Study First Received: August 4, 2011
Last Updated: September 27, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by New York Presbyterian Hospital:
MRI
Magnetic Resonance Imaging
Botox
botulinum toxin
neurological
stroke
spasticity
muscle stiffness
diffusion
Weill Cornell
New York Presbyterian Hospital
O'Dell

Additional relevant MeSH terms:
Muscle Spasticity
Stroke
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014