Therapeutic effects of repetitive transcranial magnetic stimulation therapy on central nervous system structure and function, neuromuscular properties and gait in children with cerebral palsy
Objectives: We will study therapeutic effects of repetitive transcranial magnetic stimulation (rTMS) therapy on central nervous system structure and function, neuromuscular properties and gait in children with cerebral palsy.
Design: a randomized double blind controlled study
Setting and Conduct: A hundred children with cerebral palsy will be referred to neural engineering and rehabilitation center of Noorafshar hospital from rehabilitation and medical centers. Subjects, who are diagnosed by pediatric neurologists, will be randomly allocated to study and control groups.
Major Inclusion and Exclusion criteria: Four to fourteen years old hemiplegic patients with spasticity in lower extremities who do not have metal implants or pacemaker and also have the ability of following commands will participate in this study.
Intervention: The study group will receive rTMS with air film coil and the control group will receive rTMS with sham coil. Each group will receive 25 minutes of 1 Hz repetitive transcranial magnetic stimulation for 3 days per week for 2 months.
Main outcome measures (variables): In addition to evaluating the clinical changes, brain structural changes, activity level of the descending neural pathways including corticospinal tracts, neuromuscular properties, balance, and the lower limbs movement ability of the children will be quantified.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092525568N2
Registration date:2016-11-10, 1395/08/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-10, 1395/08/20
Registrant information
Name
Seyed Mohammad Mehdi Mirbagheri
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6405 3252
Email address
mehdi@northwestern.edu
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effects of repetitive transcranial magnetic stimulation therapy on central nervous system structure and function, neuromuscular properties and gait in children with cerebral palsy
Public title
Improvement of motor function and neuromuscular disorders by repetitive transcranial magnetic stimulation therapy in children with cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: hemiplegic patients diagnosed by a pediatric neurologist; spasticity in lower extremities (Modified Ashworth Scale score more than 1); ability to attend training or test sessions; ability of following commands
Exclusion criteria: having severe mental retardation; epilepsy; chromosomal anomaly; or genetic syndrome; severe brain structural anomaly; pacemaker or any other metallic implants; not attending treatment sessions regularly
Age
From 4 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
coin-flip
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
PoorSina St., Ghods St., Enghelab St., Tehran
City
Tehran
Postal code
1417613151
Approval date
2016-01-13, 1394/10/23
Ethics committee reference number
IR.TUMS.REC.1394.1649
Health conditions studied
1
Description of health condition studied
spastic hemiplegic cerebral palsy
ICD-10 code
G80.2
ICD-10 code description
Spastic hemiplegic cerebral palsy
Primary outcomes
1
Description
Mean Diffusivity
Timepoint
before intervention; one month after the beginning of intervention; at the end of intervention; one month after the end of intervention
Method of measurement
Magnetic Resonance Imaging Acquisition; Post Analysis
2
Description
Berg Balance Scale
Timepoint
before intervention; one month after the beginning of intervention; at the end of intervention; one month after the end of intervention
Method of measurement
Clinical evaluations
3
Description
Center of Pressure Distance
Timepoint
before intervention; one month after the beginning of intervention; at the end of intervention; one month after the end of intervention
Method of measurement
Gait Analaysis
4
Description
Stride Velocity
Timepoint
before intervention; one month after the beginning of intervention; at the end of intervention; one month after the end of intervention
Method of measurement
Gait Analaysis
5
Description
Maximum Voluntary Conraction
Timepoint
before intervention; one month after the beginning of intervention; at the end of intervention; one month after the end of intervention
Method of measurement
Isokinetic
6
Description
Fractional Anisotropy
Timepoint
before intervention; one month after the beginning of intervention; at the end of intervention; one month after the end of intervention
Method of measurement
Magnetic Resonance Imaging Acquisition; Post Analysis
7
Description
Transcranial Magnetic Stimulation Motor threshold
Timepoint
before intervention; one month after the beginning of intervention; at the end of intervention; one month after the end of intervention
Method of measurement
Transcranial Magnetic Stimulation Device; Electromyography Device
8
Description
Hoffman Reflex
Timepoint
before intervention; one month after the beginning of intervention; at the end of intervention; one month after the end of intervention
Method of measurement
Electromyography Device
9
Description
Muscle Weakness
Timepoint
before intervention; one month after the beginning of intervention; at the end of intervention; one month after the end of intervention
Method of measurement
Electromyography Device
10
Description
Tissue Elasticity
Timepoint
before intervention; one month after the beginning of intervention; at the end of intervention; one month after the end of intervention
Method of measurement
Sonoelastography
11
Description
Velocity and Endorance
Timepoint
before intervention; one month after the beginning of intervention; at the end of intervention; one month after the end of intervention
Method of measurement
Clinical evaluations
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: will receive 25 minutes of 1 Hz repetitive transcranial magnetic stimulation (1500 pulses) with air film coil for 3 days per week for 8 weeks. The stimulation may be paused based on subject's tolerance.
Category
Treatment - Devices
2
Description
Control group: will receive 25 minutes of 1 Hz repetitive transcranial magnetic stimulation (1500 pulses) with sham coil for 3 days per week for 8 weeks.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Noorafshar hospital
Full name of responsible person
Maryam Shahrokhnia
Street address
Sadeghin St., Khodaverdi St., PoorEbtehaj St., Niavaran Sq., Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
Children's Medical Center
Full name of responsible person
Parmida Moradi Birgani
Street address
No 62, beside Emam Khomeini hospital, Qarib St, Keshavarz Blvd, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Seyed Mohamad Mehdi Mirbagheri
Street address
Tehran University of Medical Sciences, Pour Sina St., Ghods St., Enqelab Sq. Tehran
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 research of 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
Tehran University of Medical Sciences
Full name of responsible person
Parmida Moradi Birgani
Position
Doctor of Philosophy (PhD) student
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Pour Sina St., Ghods St., Enqelab Sq.
City
Tehran
Postal code
1417613151
Phone
+98 21 6646 6383
Fax
Email
parmida.mb@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Mohamad Mehdi Mirbagheri
Position
Post Doctoral
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Pour Sina St., Ghods St., Enqelab Sq.
City
Tehran
Postal code
1417613151
Phone
+98 21 6646 6383
Fax
Email
mehdi@northwestern.edu
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shokoofeh Parvin
Position
Master of Science student
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Pour Sina St., Ghods St., Enqelab Sq.
City
Tehran
Postal code
1417613151
Phone
+98 21 6646 6383
Fax
Email
sh-parvin@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)