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

University of Verona

Status and phase: Completed; Phase 4

Conditions: Cerebral Palsy and Botulinum Toxin

Treatments: Drug: Botulinum Toxin Type A

Study type: Interventional

Funder types: Other

Identifiers

NCT01276015

CE1780

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 25 months to 9 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

botulinum toxin A

Experimental group

Description:

botulinum toxin A diffusion in cerebral palsy

Treatment:

Drug: Botulinum Toxin Type A