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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
Universita di Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

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

25 Months - 9 Years (Child)All SexesDoes not accept 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

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

    First Posted
    January 10, 2011
    Last Updated
    January 18, 2011
    Sponsor
    Universita di Verona
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    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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