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

Longitudinal chemodenervation effects of botulinum toxin A after intramuscular application and the impact of physical activity - BoNT- physical activity and chemodenervation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003117-25-AT

Enrollment

Registered

2018-04-06

Start date

2018-05-17

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spastic hemiparesis with involvement of the M. biceps brachii

Interventions

Trade Name: Xeomin Product Name: Xeomin Pharmaceutical Form: Powder and solution for solution for injection CAS Number: 93384-43-1 Other descriptive name: BOTULINUM TOXIN TYPE A Concentration unit: U

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: -Visualizing and monitoring the emerging denervation edema after BoNT injection in the MBB and drawing correlations with BoNT induced muscle weakness by measurement of clinical parameters -To assess whether physical exercise (two groups with/without exercise) influences the size of the denervation edema and/or the extent of botulinum toxin induced weakness;Secondary Objective: -To illustrate MRI alterations with the temporally closest imaging to the clinical onset of BoNT effect -To assess whether the time of onset of the clinical effect after BoNT injection is influenced by muscle work -To demonstrate long term structural alterations in the SBB after BoNT injection;Primary end point(s): Monitoring of the emerging denervation edema after intramuscular Botulinumtoxin injection and the correlation with induced muscle weakness and reduction of spasticity measured by clinical examination and dynamometric assessment;Timepoint(s) of evaluation of this end point: baseline (before BoNT injection) and 7 times after injection: at day 1,3,7,14, 21 and after 8 and 16 weeks	—

Measure

Time frame

Main Objective: -Visualizing and monitoring the emerging denervation edema after BoNT injection in the MBB and drawing correlations with BoNT induced muscle weakness by measurement of clinical parameters -To assess whether physical exercise (two groups with/without exercise) influences the size of the denervation edema and/or the extent of botulinum toxin induced weakness;Secondary Objective: -To illustrate MRI alterations with the temporally closest imaging to the clinical onset of BoNT effect -To assess whether the time of onset of the clinical effect after BoNT injection is influenced by muscle work -To demonstrate long term structural alterations in the SBB after BoNT injection;Primary end point(s): Monitoring of the emerging denervation edema after intramuscular Botulinumtoxin injection and the correlation with induced muscle weakness and reduction of spasticity measured by clinical examination and dynamometric assessment;Timepoint(s) of evaluation of this end point: baseline (before BoNT injection) and 7 times after injection: at day 1,3,7,14, 21 and after 8 and 16 weeks

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: baseline (before BoNT injection) and 7 times after injection: at day 1,3,7,14, 21 and after 8 and 16 weeks;Secondary end point(s): -To illustrate MRI alterations with the temporally closest imaging to the clinical onset of BoNT effect -To assess whether the time of onset of the clinical effect after BoNT injection is influenced by muscle work -To demonstrate long term structural alterations in the SBB after BoNT injection	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: baseline (before BoNT injection) and 7 times after injection: at day 1,3,7,14, 21 and after 8 and 16 weeks;Secondary end point(s): -To illustrate MRI alterations with the temporally closest imaging to the clinical onset of BoNT effect -To assess whether the time of onset of the clinical effect after BoNT injection is influenced by muscle work -To demonstrate long term structural alterations in the SBB after BoNT injection

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026