Spread And Effectiveness Of Botulinum Neurotoxin A In Spastic Equinus In Cerebral Palsy
|ClinicalTrials.gov Identifier: NCT01276015|
Recruitment Status : Completed
First Posted : January 13, 2011
Last Update Posted : January 19, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy and Botulinum Toxin||Drug: Botulinum Toxin Type A||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SPREAD AND EFFECTIVENESS OF BOTULINUM NEUROTOXIN A IN SPASTIC EQUINUS IN CEREBRAL PALSY:SHORT-TERM STUDY|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||May 2010|
Experimental: botulinum toxin A
botulinum toxin A diffusion in cerebral palsy
Drug: Botulinum Toxin Type A
BoNT-A (Dysport, Ipsen) ,into the medial gastrocnemius (MG) and LG muscles unilaterally on the affected spastic hemiplegic side; dose mean± SE, 283.3± 24.7 U.. The mean dose/kg injected was 14.4± 0.8, range from 8.5 to 20 U/kg, diluted in 2.5 ml saline. frequency: once.
Other Name: dysport, ipsen
- 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 [ Time Frame: 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
- the short-term clinical effect of BoNT-A injected within standard dose ranges on changes in gait in children with CP [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276015
|Study Director:||laura bertolasi, md||Universita di Verona|