Trial document




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  DRKS00003696

Trial Description

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Title

Modulation of cerebral somatosensory processing and nociception by treatment with botulinum toxin A in spasticity and dystonia

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Trial Acronym

[---]*

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URL of the Trial

http:///

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Brief Summary in Lay Language

The sensory perception of our environment affects large parts of the human brain. It is foundamental for feeling, orientation and decision-making in humans. The brain and the so called cortex are able to process and analyze simultaneously many incoming information.
Today we know that different brain areas communicate like sophisticated networks. Certain diseases, such as spasticity or dystonia, can irritate and disrupt those communication pathways.
The aim of this study is to investigate which brain areas are “malfunctioning” in spasticity and dystonia and in which extend the therapy with botulinum toxin A corrects the "wrong" function.

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Brief Summary in Scientific Language

Intramuscular injection of botulinum toxin A for treatment in specific movement disorders (such as focal dystonia and spastic syndromes in adults and children) is an an effective therapeutic option. Due to active uptake mechanisms located at the presynaptic membrane muscle fibers with high activity are preferred.
Besides motor symptoms, these movement disorders are often associated with unpleasant sensations and pain. In addition recent studies gave clear evidence that in focal dystonia alterations of haptic perception are not limited to the affected body region.
In daily clinical practice, the treatment botulinum toxin improves not only motor symptoms but reduces pain and improves sensory perception. It is known that besides local mechanisms there are also modulations on spinal and cerebral levels.
It remains unclear, how a peripheral motor paralysis leads to persistent functional and structural changes in brain regions that are involved in the processing of somatosensory and nociceptive stimuli.
The aim of this project is to analyze changes in the somatosensory and nociceptive processing in patients with spasticity and focal dystonia under the treatment with botulinum toxin A.

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Organizational Data

  •   DRKS00003696
  •   2012/04/13
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  •   yes
  •   Approved
  •   3353-01/12, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

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Health Condition or Problem studied

  •   G24.9 -  Dystonia, unspecified
  •   R25.2 -  Cramp and spasm
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Interventions/Observational Groups

  •   control group (healthy), structural and functional mri
  •   Dystonia, structural and functional MRI study before and during treatment with botulinum toxin A (0, 3, 12 months)
  •   spasticity, structural and functional MRI study before and during treatment with botulinum toxin A (0, 3, 12 months)
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Treatment response in group 1 (dystonia) and group 2 (spasticity) after 12 months under treatment with botulinum toxin:
- Dystonia: UDRS (Unified Dystonia Rating Scale), TWSTRS (Toronto Western Spasmodic Torticollis Rating Scale)
- Spasticity: MAS (Mod Ashworth scale), SERS (Spasticity Examination Rating Scale)

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Secondary Outcome

Pain reduction (interview with "German Pain Questionnaire") at 0, 3 and 12 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/04/04
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   35   Years
  •   65   Years
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Additional Inclusion Criteria

Group 1 (dystonia): evidence of cervical dystonia by a specialist for Neurology, exclusion of other causes for dystonia-like symptomes, right-handed, no other neurological diseases, no pre-medication, MRI compatibility

Group 2 (spasticity): evidence of clinically significant spasticity of the right side of the body following an ischemic infarction by a media, right-handed, no other neurological diseases, no relevant pre-medication, MRI compatibility

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Exclusion Criteria

Psychiatric comorbidity, counter indication for MRI

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Addresses

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Sources of Monetary or Material Support

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    • Klinik für Neurologie FSU Jena
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    •   03641/9323410
    •   03641/9323412
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    • Merz Pharma GmbH & Co. KGaA Zentrale
    • Eckenheimer Landstraße 100
    • 60318  Frankfurt am Main
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.