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

NCT01412008 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2013-10-01

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • New York Presbyterian Hospital

    lead OTHER

Principal Investigators

  • Michael W O'Dell, MD · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01412008 on ClinicalTrials.gov