Objectives: Studying the Effects of Cerebrolysin on the Improvement of Spasticity and Behavioral Development of Patients with Cerebral Palsy.
Design: Non-randomized, non_blinded, single-center.
Study population: Participants of study include 6 to 12 years old patients with cerebral palsy.
Major inclusion criteria: 1. Patients 6 to 12 years old 2. Participants with cerebral palsy without persistent seizure attacks.
Major exclusion criteria: 1. The co-morbidity of cerebral palsy with persistent seizure attacks.
2.Presence of renal failure in participants.
Intervention: Administration of 0.1 cc/Kg dose of Cerebrolysin IM injection to participants, 5 times a week for one month. Participants would give one month break without injection. For the third month, Cerebrolysin would be administered to the participants at the 0.1 cc/Kg dose as IM injection at the following orders: four times per week in the first week, three times per week in the second week, two times per week in the third week and once a week for the fourth week. The injection would be continued once a week for six months if the improvement in spasticity being observed followed the fourth week of the second course of treatment.
Main outcome measures: The main purpose of study is to assess the improvement of spasticity in patients with cerebral palsy by using the Asworth's Modified Scale (AMS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107226907N3
Registration date:2015-12-02, 1394/09/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-02, 1394/09/11
Registrant information
Name
Mahmoudreza Ashrafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6612 9252
Email address
ashrafim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the Effects of Cerebrolysin on the Improvement of Spasticity and Behavioral Development of Patients with Cerebral Palsy
Public title
The effect of Cerebrolysin in cerebral palsy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria includes:
1. Participants must be 6 to 12 years old.
2. Participants must be free of grand mal seizure attacks.
Exclusion criteria includes:
1. Participants with diagnosis of cerebral palsy and grand mal seizure attacks co-morbidity have been excluded of the study.
2. Participants with renal failure disorder would not be participated in the study.
Age
From 6 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Research department, Tehran University of Medical Sciences' headquarters, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2015-04-08, 1394/01/19
Ethics committee reference number
142077-9111165027
Health conditions studied
1
Description of health condition studied
Cerebral Palsy
ICD-10 code
G80
ICD-10 code description
Excl: hereditary spastic paraplegia
2
Description of health condition studied
Spastic diplegic cerebral palsy
ICD-10 code
G80
ICD-10 code description
Congenital spastic paralysis (cerebral) Spastic cerebral palsy NOS
3
Description of health condition studied
Spastic quadriplegic cerebral palsy
ICD-10 code
G80.0
ICD-10 code description
Spastic tetraplegic cerebral palsy
4
Description of health condition studied
Spastic hemiplegic cerebral palsy
ICD-10 code
G80.2
ICD-10 code description
Spastic hemiplegic cerebral palsy
5
Description of health condition studied
Dyskinetic cerebral palsy
ICD-10 code
G80.3
ICD-10 code description
Athetoid cerebral palsy Dystonic cerebral palsy
6
Description of health condition studied
Ataxic cerebral palsy
ICD-10 code
G80.4
ICD-10 code description
Ataxic cerebral palsy
7
Description of health condition studied
Other cerebral palsy
ICD-10 code
G80.8
ICD-10 code description
Mixed cerebral palsy syndromes
8
Description of health condition studied
Cerebral palsy, unspecified
ICD-10 code
G80.9
ICD-10 code description
Cerebral palsy NOS
9
Description of health condition studied
Spastic diplegic cerebral palsy
ICD-10 code
G80.1
ICD-10 code description
Congenital spastic paralysis (cerebral) Spastic cerebral palsy NOS
Primary outcomes
1
Description
Degree of improvement in spapsticity
Timepoint
Before intervention, At the end of the first month of treatment course, At the end of third month of second course of intervention
Method of measurement
Asworth Scoring
Secondary outcomes
empty
Intervention groups
1
Description
Administration of 0.1 cc/Kg dose of Cerebrolysin IM injection to participants, 5 times a week for one month. Participants would give one month break without injection. For the third month, Cerebrolysin would be administered to the participants at the 0.1 cc/Kg dose as IM injection at the following orders: four times per week in the first week, three times per week in the second week, two times per week in the third week and once a week for the fourth week. The injection would be continued once a week for six months if the improvement in spasticity being observed followed the fourth week of the second course of treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology Clinic of Children's Medical Center
Full name of responsible person
Dr. Elnaz Fattah Dizaji
Street address
Children's Medical center,62 QaribSt., KeshavarzBlvd.,Tehran 14194,Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Reseach, Tehran university of medical sciences
Full name of responsible person
Dr.Masoud Younesian
Street address
Research department, Tehran university of medical sciences' head quarters, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Reseach, Tehran university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Children's Medical Center
Full name of responsible person
Elnaz Fattah Dizaji
Position
Pediatrics Resident
Other areas of specialty/work
Street address
Children's Medical Center, Dr.Mohammad Gharib street
City
Tehran
Postal code
Phone
+98 21 2242 9571
Fax
Email
dr.el.fattah@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Children's Medical Center
Full name of responsible person
Elnaz Fattah Dizaji
Position
Pediatrics Resident
Other areas of specialty/work
Street address
Children's Medical Center, Dr. Mohammad Gharib street
City
Tehran
Postal code
Phone
+98 21 2242 9571
Fax
Email
dr.el.fattah@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Children's medical center
Full name of responsible person
Elnaz Fattah Dizaji
Position
Pediatrics Resident
Other areas of specialty/work
Street address
Children's Medical Center, Dr.Mohammad Gharib street
City
Tehran
Postal code
Phone
+98 21 2242 9571
Fax
Email
dr.el.fattah@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)