Cerebrolysin Neural Repair Therapy in Children With Traumatic Brain Injury and Cerebral Palsy

Study Overview
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Brief Summary
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Cerebral palsy (CP) is the most frequent cause of motor handicap among children. The economic burden of CP in USA includes $1.18 billion in direct medical costs, $1.05 billion in direct non-medical costs, and an additional $9.24 billion in indirect costs, for a total cost of $11.5 billion or $921,000 average cost per person. Associated disabilities as mental retardation, delayed speech development add psychological burden of the disease on the family as well as economic burden. Mental retardation is the major problem in children with cerebral palsy. Improving mental development will have a positive effect on quality of life for the child and his family. Treating associated impairments (mental retardation) with Cerebrolysin will improve mental development and quality of life, and will decrease the economic burden in children with cerebral palsy.

Official Title
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Effect of Nerve Growth Factor (Cerebrolysin) Therapy on Neurodevelopment, Sleep Pattern and Quality of Life in Children With Traumatic Brain Injury and Cerebral Palsy

Conditions
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Cerebral Palsy Children, Children With Traumatic Brain Injury, Mental Handicap, Delayed Speech Development

Intervention / Treatment
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* Drug: Cerebrolysin (Nerve growth factor)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cerebral palsy with mental retardation Severe perinatal brain insult Exclusion Criteria: Severe growth retardation Gastrostomy tube feeding Intractable seizures. Severe motor handicap and deformities from long standing spasticity. Congenital malformations. Suspected inborn error of metabolism. Suspected inherited neurologic disease. Children with auditory and visual impairments. Care giver's refusal to participate in the study.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cerebrolysin<br>Nerve growth factor Cerebrolysin will be given to the intervention group | Drug: Cerebrolysin (Nerve growth factor)<br>* Cerebrolysin will be given to the intervention group<br>* Other names: Cerebrolysin;|
| No Intervention: Conventional<br>These children will receive conventional treatment for cerebral palsy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurodevelopment | Intelligence quotient (IQ) assessment at base line and after 3 and 6 month of therapy | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral palsy children, Cerebrolysin, Sleep questionnaire, Quality of life, Bayley III scale