Spread And Effectiveness Of Botulinum Neurotoxin A In Spastic Equinus In Cerebral Palsy

Phase 4

Completed

• Conditions: Cerebral Palsy and Botulinum Toxin
• Interventions: Drug: Botulinum Toxin Type A

• Registration Number: NCT01276015
• Lead Sponsor: Universita di Verona

Brief Summary

Objectives. To study the short-term neurophysiological and clinical outcome of botulinum toxin type A(BoNT-A), injected at standard doses, and assess toxin spread to neighboring uninjected muscles in children with cerebral palsy.

Subjects and methods. The investigators studied 18 ambulatory children with dynamic equinus foot deformity (mean age 6.1 years). The gastrocnemius muscle on the affected side was injected with BoNT-A (Dysport, range from 8.9-19.4 U/kg). As the primary neurophysiological outcome measure, compound muscle action potential (CMAP) areas were assessed in the lateral gastrocnemius (LG) and tibialis anterior(TA) muscles on the treated and untreated side before BoNT-A injections (T0), and on days 10 (T10), and 30 (T30) after injections. Clinical scales were assessed and video gait was analyzed at all three time points.

Results. In all patients, CMAP areas recorded from the LG and TA muscles on the treated side decreased significantly from pre-injection values at T10 (p\<0.05) and T30 (p\<0.002). Assessment at both time points after injections also showed that ankle spasticity had diminished (p\<0.05), equinus foot excursion increased (p\<0.05), and functional gait improved (p\<0.05).

Conclusion. Although BoNT-A injected at standard doses improves gait in children with spastic equinus foot the toxin spreads to uninjected leg muscles. BoNT-A treatment for cerebral palsy therefore needs individualizing according to the child's clinical features.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-11
• Study Start: 2009-12
• Primary Completion: 2010-02
• Study Completion: 2010-05
• Study First Submitted: 2011-01-10
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-13
• Last Update Submitted: 2011-01-18
• Last Update Posted: 2011-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• spasticity refractory to oral medication
• patients able to walk independently or with aid
• no contraindications to BoNT-A treatment such as fixed contracture,aminoglycoside therapy and myasthenia gravis and no other neuromuscular diseases
• no orthopedic surgery before
• normal or mildly declined cognition
• previous treatment at least six months before the study

Exclusion Criteria

• all contraindications to BoNT-A treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
botulinum toxin A	Botulinum Toxin Type A	botulinum toxin A diffusion in cerebral palsy

Primary Outcome Measures

Name	Time	Method
BoNT-A injected into gastrocnemius within standard dose ranges spreads to surrounding anterior lower-limb muscles in children with CP and induces chemodenervation in injected muscles	one month	As the primary neurophysiological outcome measure of BoNT-A induced paresis and spread, we studied changes in compound muscle action potential (CMAP) areas recorded from the lateral gastrocnemius (LG) muscle after injecting BoNT-A and from the ipsilateral tibialis anterior (TA) muscle in children with spastic hemiplegia. In line with others we considered a decreased CMAP area from LG muscle injected with BoNT-A as the neurophysiological index of BoNT-A-induced paresis

Secondary Outcome Measures

Name	Time	Method
the short-term clinical effect of BoNT-A injected within standard dose ranges on changes in gait in children with CP	30 days	As the clinical outcome measures clinical scales were assessed and video gait was analyzed before BoNT-A injections (T0), and on days 10 (T10), and 30 (T30) after injections.