Muscular changes after injection of Botulinumtoxin illustrated by Magnetic Resonance Tomography over a period of 16 weeks and the impact of muscle before injectio

Phase 1

• Conditions: Spastic hemiparesis with involvement of the M. biceps brachii; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2017-003117-25-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-06
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

•Upper limb spasticity, involvement of M. biceps brachii
•Age 18-80 years
•Male and female
•modified ashworth scale score =2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

Absolute:
•patients under anticoagulation
•presence of a myasthenic syndrome, myopathies or myotonias
•presence of a cardiac pacemaker
•pregnancy and current breast feeding
Relative:
•implanted metal parts (stent, prosthesis,..), dependend on year of implantation
•claustrophobia
•inflammation at the designated injection site
- spastic tetraparesis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified