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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kirsten Elwischger, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01162291
First received: July 12, 2010
Last updated: January 28, 2012
Last verified: January 2012
  Purpose

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.


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Intramuscular Distribution of Different Injection Volumes Via Diffusion Tensor Imaging (DTI)-A Pilot Trial

Further study details as provided by Medical University of Vienna:

Enrollment: 8
Study Start Date: June 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

healthy volunteer

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01162291

Locations
Austria
Medical University of Vienna, Department of Neurology
Vienna, Austria, 1090
Sponsors and Collaborators
Kirsten Elwischger
Investigators
Principal Investigator: Thomas Sycha, Prof., MD Medical University of Vienna
  More Information

Publications:
Responsible Party: Kirsten Elwischger, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01162291     History of Changes
Other Study ID Numbers: MUW-M-MRI01
Study First Received: July 12, 2010
Last Updated: January 28, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
intramuscular
distribution
NaCl
botulinum toxin
muscle
volume
movement
biceps brachii
primary distribution of intramuscular NaCl representative for primary distribution of intramuscular botulinum toxin
shift from extracellular to intracellular viewed by DTI technology
effect of volume
effect of muscle movement

ClinicalTrials.gov processed this record on August 27, 2014