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

NCT01412008 | Completed

• 1 other identifier: 1002010863
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Muscle Spasticity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• MRI

  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.

  Baseline (0 months), 2 months and 3 months

Study Arms (1)

botox diffusion

NO INTERVENTION

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)

Interventions

Botox (botulinum toxin) DRUG

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.

botox diffusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York Presbyterian Hospital: lead

Study Sites (1)

New York Presbyterian Hospital/Weill Cornell Medical College

New York, New York, 10065, United States

Location

Related Links

• NYPH/WCMC Rehabilitation Medicine Research/Trials Site

MeSH Terms

Conditions

Stroke; Muscle Spasticity; Neurologic Manifestations

Interventions

Botulinum Toxins, Type A; Botulinum Toxins

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Michael W O'Dell, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 4, 2011
• First Posted: August 8, 2011
• Study Start: March 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 1, 2013

Record last verified: 2013-09

Locations

US (1)