Status:
COMPLETED
DTI Study of the Influence of Physiotherapy on Distribution of BoNT in Spastic Muscle
Lead Sponsor:
Kirsten Elwischger, MD
Conditions:
Spasticity
Eligibility:
All Genders
18-80 years
Brief Summary
Intramuscular application of botulinum toxin (BoNT) is used as a successful therapy of muscle spasticity. Clinical practice shows, that even with the use of special guidance techniques to increase acc...
Detailed Description
* At baseline and week 16, dynamic T2-, T2-,and DTI weighted sequences will be performed to monitor the injection of the BoNT-bolus. Immediate after MRI-scan, physiotherapy will be performed. Patients...
Eligibility Criteria
Inclusion
- willing to participate in this clinical pilot trial
- age 18-80 years
- ≥4 months under routine botulinum toxin treatment
- last botulinum toxin treatment ≥3 months before screening
- spasticity of m. biceps brachii elbow flexion: Modified Ashworth Scale (MAS) ≥3
Exclusion
- bleeding disorders or acute bleeding event.
- coumarine, warfarine therapy.
- non-MRI compatible medical (prothetics, pacemaker, etc) or non medical implantation (tattoos, intraorbital metal splinters, etc.) or other contraindications for MRI, not meeting the general safety recommendations for 3Tesla MRI.
- claustrophobia.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01523210
Start Date
November 1 2011
End Date
November 1 2012
Last Update
November 14 2012
Active Locations (1)
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1
Medical University of Vienna, Department of Neurology
Vienna, Vienna, Austria, 1090