SpasticityNCT01523210
DTI Study of the Influence of Physiotherapy on Distribution of BoNT in Spastic Muscle
An observational study of Spasticity, run by Kirsten Elwischger, MD at 1 site in Austria.
Trial 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 accuracy of targeting, BoNT may spread to adjacent sites by diffusion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spasticity
- What is being tested?
- physiotherapy
- How many people
- 5 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2011to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients suffering from upper limb spasticity receiving routine BoNT injection
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department of Neurology
Vienna, State of Vienna, 1090
About this study
Official title: Influence of Physiotherapy on the Spastic Musculus Biceps Brachii Under Routine Botulinum Toxin Injection. - An Explorative MRI Study
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 accuracy of targeting, BoNT may spread to adjacent sites by diffusion. This causes fluctuating treatment response, unintended side effects, and decrease of effect due to production of antibodies. Hence, clinicians require increase of efficacy and safety by dose reduction, improvement of injection technique, and additional treatment strategies. Referring to this, animal model showed increased efficacy and decreased systemic side effects of BoNT in the injected muscle after active or passive manipulation of muscle. The mechanism of this effect remain unclear.
T2 and (Diffusion Tensor Imaging) DTI technique can evaluate the in-vivo distribution of fluids in human skeletal muscle. In addition, it allows to differentiate denervated muscle tissue, caused by BoNT injections, from surrounding unaffected muscle tissue.
Read more
Up to the investigators knowledge, neither a human, in vivo measurement of the influence of passive muscle activity on the area of denervation, nor the primary, in-vivo distribution of BoNT within spastic human muscle tissue, been evaluated.
The aim of this explorative study is:
- to monitor the inflow and regional distribution of the injection bolus by dynamic T2-weighted-, DTI-sequences;
- to assess the effect of passive muscle exercise on the area of denervated, caused by BoNT, measured by DTI-, T2-weighted and flair sequences.
The investigators hypothesize, that
- intramuscular denervation area, measured by DTI-, T2-weighted and Fluid Attenuated Inversion Recovery (FLAIR) sequences, 3 weeks after routine BoNT injection, is facilitated by passive muscle exercise;
- primary distribution of the injected BoNT bolus can be non-invasively monitored by dynamic T2-, DTI- and T2 weighted sequences.
Therefore, in this investigator blinded, cross-over study, 6 patients suffering from upper limb spasticity, including musculus biceps brachii, will be investigated. (Magnetic Resonance Tomography) MRI of the musculus biceps brachii will be performed at two consecutive, routine BoNT-injection days (baseline and week 16). Patients receive dosage as clinically indicated, due to routine treatment. Patients will be randomised to receive thirty minutes of physiotherapy of the affected arm, including exercise of the elbow flexors, at one of the injection days (baseline, or week 16, respectively). In addition, MRI will be repeated 3 weeks after injection.
Read the 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, who were randomised to the non-treatment group at baseline, will receive physiotherapy immediately after MRI at week 16.
- At week 3 and week 19, three weeks after BoNT injection, respectively, MRI will be repeated. T2-and DTI- weighted and FLAIR- sequences will be performed.
- Conditions
- Spasticity
- Being tested
- physiotherapy
- Keywords
- spasticity, Diffusor tensor imaging, distribution, botulinum toxin, physiotherapy
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapyOther
Also called physical therapy
thirty minutes passive flexion and extension of the elbow joint by a physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| upper limb spasticity | patients suffering from upper limb spasticity and are treated with botulinum toxin Receives: Other: physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of Fractionated Anisotropie (FA) value
FA value reflects indirect diffusion
Measured: baseline, week 3, week 16, week 19
change of muscle cross-sectional area after routine botulinum toxin injection
reflected by diameter of signal changes on T2-weighted and short-tau inversion recovery (STIR) sequences
Measured: baseline, week 3, week 16, week 19
Change of Apparent Diffusion Coefficient (ADC) values
ADC describes structural changes of myocytes
Measured: baseline, week 3, week 16, week 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startNov 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsten Elwischger, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kirsten Elwischger, MD, Medical University of Vienna
- Investigators
- Thomas Sycha, Prof., MD, Principal investigator, Medical University of Vienna, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523210
- Sponsor's protocol ID
- DTI_BoNT_distribution
- Status last verified
- Nov 2012
- First submitted
- 7 Jan 2012
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Physiotherapy on the Spastic Musculus Biceps Brachii Under Routine Botulinum Toxin Injection. - An Explorative MRI Study
- ClinicalTrials.gov ID
- NCT01523210
- Acronym / sponsor ID
- DTI_BoNT_distribution
- Conditions
- Spasticity
- Keywords
- spasticity, Diffusor tensor imaging, distribution, botulinum toxin, physiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Kirsten Elwischger, MDUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 accuracy of targeting, BoNT may spread to adjacent sites by diffusion. This causes fluctuating treatment response, unintended side effects, and decrease of effect due to production of antibodies. Hence, clinicians require increase of efficacy and safety by dose reduction, improvement of injection technique, and additional treatment strategies. Referring to this, animal model showed increased efficacy and decreased systemic side effects of BoNT in the injected muscle after active or passive manipulation of muscle. The mechanism of this effect remain unclear.
T2 and (Diffusion Tensor Imaging) DTI technique can evaluate the in-vivo distribution of fluids in human skeletal muscle. In addition, it allows to differentiate denervated muscle tissue, caused by BoNT injections, from surrounding unaffected muscle tissue.
Up to the investigators knowledge, neither a human, in vivo measurement of the influence of passive muscle activity on the area of denervation, nor the primary, in-vivo distribution of BoNT within spastic human muscle tissue, been evaluated.
The aim of this explorative study is:
- to monitor the inflow and regional distribution of the injection bolus by dynamic T2-weighted-, DTI-sequences;
- to assess the effect of passive muscle exercise on the area of denervated, caused by BoNT, measured by DTI-, T2-weighted and flair sequences.
The investigators hypothesize, that
- intramuscular denervation area, measured by DTI-, T2-weighted and Fluid Attenuated Inversion Recovery (FLAIR) sequences, 3 weeks after routine BoNT injection, is facilitated by passive muscle exercise;
- primary distribution of the injected BoNT bolus can be non-invasively monitored by dynamic T2-, DTI- and T2 weighted sequences.
Therefore, in this investigator blinded, cross-over study, 6 patients suffering from upper limb spasticity, including musculus biceps brachii, will be investigated. (Magnetic Resonance Tomography) MRI of the musculus biceps brachii will be performed at two consecutive, routine BoNT-injection days (baseline and week 16). Patients receive dosage as clinically indicated, due to routine treatment. Patients will be randomised to receive thirty minutes of physiotherapy of the affected arm, including exercise of the elbow flexors, at one of the injection days (baseline, or week 16, respectively). In addition, MRI will be repeated 3 weeks after injection.
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, who were randomised to the non-treatment group at baseline, will receive physiotherapy immediately after MRI at week 16.
- At week 3 and week 19, three weeks after BoNT injection, respectively, MRI will be repeated. T2-and DTI- weighted and FLAIR- sequences will be performed.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| upper limb spasticity | – | Other: physiotherapypatients suffering from upper limb spasticity and are treated with botulinum toxin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients suffering from upper limb spasticity receiving routine BoNT injection
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physiotherapyAlso: physical therapythirty minutes passive flexion and extension of the elbow joint by a physiotherapist | Other | upper limb spasticity |
Primary outcome
change of Fractionated Anisotropie (FA) value
Time frame: baseline, week 3, week 16, week 19
FA value reflects indirect diffusion
change of muscle cross-sectional area after routine botulinum toxin injection
Time frame: baseline, week 3, week 16, week 19
reflected by diameter of signal changes on T2-weighted and short-tau inversion recovery (STIR) sequences
Change of Apparent Diffusion Coefficient (ADC) values
Time frame: baseline, week 3, week 16, week 19
ADC describes structural changes of myocytes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Sycha, Prof., MD principal investigator
Medical University of Vienna, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spasticity, run by Kirsten Elwischger, MD at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of Fractionated Anisotropie (FA) value (time frame: baseline, week 3, week 16, week 19). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2012.