Cerebral Palsy and Botulinum Toxin Clinical Trial
Official title:
SPREAD AND EFFECTIVENESS OF BOTULINUM NEUROTOXIN A IN SPASTIC EQUINUS IN CEREBRAL PALSY:SHORT-TERM STUDY
| Verified date | November 2009 |
| Source | Universita di Verona |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 18 |
| Est. completion date | May 2010 |
| Est. primary completion date | February 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 25 Months to 9 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Universita di Verona |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | one month | Yes |
| Secondary | the short-term clinical effect of BoNT-A injected within standard dose ranges on changes in gait in children with CP | 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. | 30 days | Yes |