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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02116348

Enrollment

100

Registered

2014-04-16

Start date

2014-04-30

Completion date

2016-04-30

Last updated

2014-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Cerebral palsy children, Cerebrolysin, Sleep questionnaire, Quality of life, Bayley III scale

Brief summary

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.

Interventions

DRUGCerebrolysin (Nerve growth factor)

Cerebrolysin will be given to the intervention group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Months to 18 Years

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.

Design outcomes

Primary

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

Countries

Egypt

Contacts

Primary ContactSahar M.A. Hassanein, MD

saharhassanein@med.asu.edu.eg201223183943

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026