DTI Study of the Influence of Physiotherapy on Distribution of BoNT in Spastic Muscle

NCT01523210 | Completed

• 1 other identifier: DTI_BoNT_distribution
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Spasticity

Keywords

spasticity; Diffusor tensor imaging; distribution; botulinum toxin; physiotherapy

Outcome Measures

Primary Outcomes (3)

• change of Fractionated Anisotropie (FA) value

  FA value reflects indirect diffusion

  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

  baseline, week 3, week 16, week 19

• Change of Apparent Diffusion Coefficient (ADC) values

  ADC describes structural changes of myocytes

  baseline, week 3, week 16, week 19

Study Arms (1)

upper limb spasticity

patients suffering from upper limb spasticity and are treated with botulinum toxin

Other: physiotherapy

Interventions

physiotherapy OTHER

thirty minutes passive flexion and extension of the elbow joint by a physiotherapist

Also known as: physical therapy

upper limb spasticity

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients suffering from upper limb spasticity receiving routine BoNT injection

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kirsten Elwischger, MD: lead

Study Sites (1)

Medical University of Vienna, Department of Neurology

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Muscle Spasticity

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Thomas Sycha, Prof., MD

  Medical University of Vienna, Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 7, 2012
• First Posted: February 1, 2012
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 14, 2012

Record last verified: 2012-11

Locations

AU (1)