Clinical trial NCT01276015: Spread And Effectiveness Of Botulinum Neurotoxin A In Spastic Equinus In Cerebral Palsy
Official title: SPREAD AND EFFECTIVENESS OF BOTULINUM NEUROTOXIN A IN SPASTIC EQUINUS IN CEREBRAL PALSY:SHORT-TERM STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cerebral Palsy and Botulinum Toxin
Keywords: BoNT-A-botulinum neurotoxin type A
CMAP-compound muscle action potential
CP-cerebral palsy
LG-lateral gastrocnemius
MG-medial gastrocnemius
TA-tibialis anterior
PROMS-passive range of movement
MAS-modified Ashworth scale
EVGS-Edinburgh visual gait scale
GMF-CS-gross motor function classification system
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2011-01-13
Enrollment: 18
Sex: ALL
Minimum age (years): 25
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: one month
Secondary outcomes:
measure: the short-term clinical effect of BoNT-A injected within standard dose ranges on changes in gait in children with CP
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Universita di Verona
name: laura bertolasi, md
role: STUDY_DIRECTOR
References: