Spread And Effectiveness Of Botulinum Neurotoxin A In Spastic Equinus In Cerebral Palsy
Primary Purpose
Cerebral Palsy and Botulinum Toxin
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy and Botulinum Toxin focused on measuring 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
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
botulinum toxin A
Arm Description
botulinum toxin A diffusion in cerebral palsy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01276015
First Posted
January 10, 2011
Last Updated
January 18, 2011
Sponsor
Universita di Verona
1. Study Identification
Unique Protocol Identification Number
NCT01276015
Brief Title
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
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universita di Verona
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
botulinum toxin A
Arm Type
Experimental
Arm Description
botulinum toxin A diffusion in cerebral palsy
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
dysport, ipsen
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
one month
Secondary Outcome Measure Information:
Title
the short-term clinical effect of BoNT-A injected within standard dose ranges on changes in gait in children with CP
Description
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.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Months
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
laura bertolasi, md
Organizational Affiliation
Universita di Verona
Official's Role
Study Director
12. IPD Sharing Statement
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Spread And Effectiveness Of Botulinum Neurotoxin A In Spastic Equinus In Cerebral Palsy
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