Comparison of Intramuscular Distribution of Different Injection Volumes Via Diffusion Tensor Imaging (DTI)

January 28, 2012 updated by: Kirsten Elwischger

Comparison of Intramuscular Distribution of Different Injection Volumes Via Diffusion Tensor Imaging (DTI)-A Pilot Trial

The purpose of this experimental pilot study is to assess a positive effect of higher injection volumes of fluid (physiological sodium) in the elbow-flection-muscle (M. biceps brachii) and elbow flexion and extension movements on fluid distribution in the muscle tissue.

Study Overview

Status

Completed

Conditions

Detailed Description

Background:

Intramuscular application of Botulinum toxin is used as a successful therapy of many conditions (e.g. spasticity, movement disorders, hypersecretory disorders, ophthalmic disorders, painful conditions, pelvic floor and gastrointestinal disorders, cosmetic applications) Clinical practice shows that even with the use of special guidance techniques (electromyography (EMG), ultrasound, electrical stimulation) to increase accuracy of targeting, botulinum toxin may spread to adjacent sites by diffusion. Different therapy goals request variable diffusion of the toxin, depending on the number of muscles involved and loss of function in the affected area, respectively. There is some evidence that larger injection volume lead to greater distribution and a larger affected area. Thus, animal model showed increased efficacy and decreased systemic side effects of botulinum toxin A in the injected muscle after active or passive manipulation of muscle.

Magnetic resonance imaging (MRI) has the potential to noninvasively probe the amount and motion of intracellular and extracellular water using different sequences. T2-weighted and diffusion tensor sequences are especially useful in the quantification and characterization of the chemical behaviour of water in different (animal) tissue types. To our knowledge there has been no systematically performed in vivo MR study using these imaging techniques in the visualization of intramuscular dilution of fluid in human subjects. However, the in vivo effect on tissue distribution of different injection volumes and active muscle movement in humans via DTI has never been observed.

Hypothesis:

Intramuscular distribution of common saline solutions can be non-invasively quantified by DTI in human subjects. DTI can be used to elucidate if:

  • Intramuscular distribution is favoured by larger injection volumes and
  • Intramuscular distribution is facilitated by active muscle activity.

Rationale:

The effect of large injection volumes and active muscle activity after injection on intramuscular toxin distribution and uptake remains unclear. Physiological sodium is the carrier material of all preparations of Botulinum toxin, suggesting that physiological sodium or natriumchlorid (NaCl) distribution is representative for toxin primary distribution. Dynamic T2-weighted sequences may monitor the inflow and regional distribution of the infused saline solution.

DTI can non-invasively quantify the amount and directionality of motion of protons in human skeletal muscle and may therefore indirectly allow assumptions on the extra- and intracellular distribution of the infused solution/substance.

Methods:

In this exploratory, investigator blinded pilot study, 10 healthy subjects will be investigated by DTI of the musculi biceps brachii after randomised intramuscular injection of two different injection volumes of NaCl and randomisation to active flexion and extension in the elbow joints versus no active flexion and extension. During each injection dynamic T2 weighted magnetic resonance tomographic sequences will be performed. Subsequently diffusion tensor sequences will be carried out at defined time points.

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna, Department of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

healthy volunteer

Description

Inclusion Criteria:

  • healthy volunteer
  • willing to participate in this clinical pilot trial
  • age 18-80 years old

Exclusion Criteria:

  • bleeding disorder or acute bleeding event
  • coumarines, warfarin therapy
  • any type of medical implant (pacemaker, prosthesis, etc.) not meeting the general safety recommendations for 3 tesla MR imaging

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
movement
healthy subjects, randomised to do flexion and extension movements with their left and right elbow joint after intramuscular application of NaCl 2ml in the right musculus biceps brachii, and 1ml in the left musculus biceps brachii
rest
healthy subjects are randomised to rest after intramuscular application of NaCl 1ml in the left and 2ml in the right musculus biceps brachii

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirsten Elwischger

Investigators

  • Principal Investigator: Thomas Sycha, Prof., MD, Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

July 12, 2010

First Submitted That Met QC Criteria

July 13, 2010

First Posted (Estimate)

July 14, 2010

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 28, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MUW-M-MRI01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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