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

July 12, 2010
January 28, 2012
June 2010
January 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01162291 on ClinicalTrials.gov Archive Site
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Comparison of Intramuscular Distribution of Different Injection Volumes Via Diffusion Tensor Imaging (DTI)
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

healthy volunteer

Healthy
Not Provided
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01162291
MUW-M-MRI01
No
Kirsten Elwischger, Medical University of Vienna
Kirsten Elwischger
Not Provided
Principal Investigator: Thomas Sycha, Prof., MD Medical University of Vienna
Medical University of Vienna
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP