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

April 15, 2014 updated by: Sahar M.A. Hassanein, MD, Ain Shams University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abassia
      • Cairo, Abassia, Egypt, 11381
        • Recruiting
        • Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University
        • Contact:
        • Sub-Investigator:
          • Tarek A. Abdo, MD, PhD
        • Sub-Investigator:
          • Neveen T. Younis, MD, PhD
        • Sub-Investigator:
          • Iman AA Elagouza, MD, PhD
        • Sub-Investigator:
          • Shaymaa A Maher, MD, PhD
        • Sub-Investigator:
          • Eman A.M. Medany, M.SC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cerebrolysin
Nerve growth factor Cerebrolysin will be given to the intervention group
Drug: Cerebrolysin (Nerve growth factor)
Cerebrolysin will be given to the intervention group
Other Names:
  • Cerebrolysin
No Intervention: Conventional
These children will receive conventional treatment for cerebral palsy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Sahar M.A. Hassanein, MD, PhD, Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (Estimate)

April 16, 2014

Study Record Updates

Last Update Posted (Estimate)

April 16, 2014

Last Update Submitted That Met QC Criteria

April 15, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWA 000017585

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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