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

Ain Shams University

Status and phase: Unknown; Phase 2

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

Treatments: Drug: Cerebrolysin (Nerve growth factor)

Study type: Interventional

Funder types: Other

Identifiers

NCT02116348

FWA 000017585

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 3 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cerebral palsy with mental retardation
• Severe perinatal brain insult

Exclusion criteria

1. Severe growth retardation
2. Gastrostomy tube feeding
3. Intractable seizures.
4. Severe motor handicap and deformities from long standing spasticity.
5. Congenital malformations.
6. Suspected inborn error of metabolism.
7. Suspected inherited neurologic disease.
8. Children with auditory and visual impairments.
9. Care giver's refusal to participate in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Cerebrolysin

Experimental group

Description:

Nerve growth factor Cerebrolysin will be given to the intervention group

Treatment:

Drug: Cerebrolysin (Nerve growth factor)

Conventional

No Intervention group

Description:

These children will receive conventional treatment for cerebral palsy