assessing effect of anodal stimulation of Cz (motor cortical area) using tDCS on children with diplegic spastic cerebral palsy
Design
Randomized, double blind, sham controlled, crossover clinical trial on 20 diplegic spastic cerebral palsy children. Randomization was done with Sealed Envelope Ltd. 2021.
Settings and conduct
20 spastic-diplegic CP patients will be randomized in two groups of active and sham tDCS. Patients and investigators are blinded. In both groups pre-study evaluation and gait analysis will be done. Then 5 sessions of active or sham tDCS will be performed. All the evaluations and gait analysis will be repeated after one week. After one month of washout period the groups will be crossed and a course of tDCS will be performed. After one week all the evaluations will be repeated.
Participants/Inclusion and exclusion criteria
Patient with diplegic spastic cerebral palsy aging between 5 and 7 years will be included. Patients who have history of surgery in previous year, uncontrolled epilepsy, metallic foreign body in brain, needing urgent orthopedic surgery or cognitive problem troubling cooperation will be excluded.
Intervention groups
In intervention group direct electrical stimulation is performed using saline wet sponge; anode is placed on cortical motor area Cz and cathode is placed on forehead. There will be 30 seconds of ascending direct current at the beginning, thereafter 20 minutes of stable 2 mA current and at the end 30 seconds of descending current will be employed.
In the sham (placebo) group ascending and descending currents will be employed at the beginning and the end but in the middle 20 minutes there will be no stimulation.
Main outcome variables
Gait velocity
Gait cadence
PEDI : Pediatric evaluation of disability inventory
6MWT: six minute walk test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170703034879N3
Registration date:2021-07-31, 1400/05/09
Registration timing:prospective
Last update:2021-07-31, 1400/05/09
Update count:0
Registration date
2021-07-31, 1400/05/09
Registrant information
Name
Siamak Abdi
Name of organization / entity
Neurology department- shariati hospital- Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 1321
Email address
s-abdi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of transcranial direct current stimulation effect on gait in children with diplegic spastic cerebral palsy
Public title
Effect of transcranial direct current stimulation in diplegic cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diplegic spastic cerebral palsy
Gross Motor Function Classification System (GMFCS) less than 4, i.e. can walk independently or with walking aid
age between 5 and 12 years
Exclusion criteria:
patient or parents do not consent
history of surgery in previous 12 months
uncontrolled epilepsy
metallic foreign body in brain
orthopedic problem needing urgent surgery
cognitive problem troubling cooperation
Age
From 5 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
We will use computer-generated randomization. Five blocks of 4 will be made by third party not involving in the study and randomization list will be generated. Neither investigator nor patients know the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
A third party will make randomization list. The list will be given to investigator. Investigator, occupational therapist, outcome assessor and patients are blinded to the groups. After completion of study blinding will be removed. Data analyzer will not be blinded to the groups.
Placebo
Used
Assignment
Crossover
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
Neurology department, Shariati Hospital, North Kargar Street
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2021-06-27, 1400/04/06
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.354
Health conditions studied
1
Description of health condition studied
spastic diplegic Cerebral palsy
ICD-10 code
G80.1
ICD-10 code description
Spastic diplegic cerebral palsy
Primary outcomes
1
Description
velocity of gait
Timepoint
gait velocity will be measured 1 week after the completion of first and second course (after crossover) of tDCS
Method of measurement
Measured during gait analysis by velocity sensors
Secondary outcomes
1
Description
cadence
Timepoint
cadence will be measured 1 week after the completion of first and second course (after crossover) of tDCS
Method of measurement
Measured during gait analysis by velocity and time sensors
2
Description
PEDI : Pediatric evaluation of disability inventory
Timepoint
PEDI will be filled 1 week after the completion of first and second course (after crossover) of tDCS
Method of measurement
The investigator will fill the inventory.
3
Description
6MWT: six minute walk test
Timepoint
6MWT be measured 1 week after the completion of first and second course (after crossover) of tDCS
Method of measurement
The distance walked in 6 minutes will be measured by the investigator.
Intervention groups
1
Description
Intervention group: In intervention group direct electrical stimulation is performed using saline wet sponge; anode is placed on cortical motor area Cz and cathode is placed on forehead. There will be 30 seconds of ascending direct current at the beginning, thereafter 20 minutes of stable 2 mA current and at the end 30 seconds of descending current will be employed.
Category
Treatment - Devices
2
Description
Category
empty
3
Description
Control group: In the sham group direct electrical stimulation is performed using saline wet sponge; anode is placed on cortical motor area Cz and cathode is placed on forehead. There will be 30 seconds of ascending direct current at the beginning, in the next 20 minutes no current is employed. Thereafter 30 seconds of descending current will be employed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Siamak Abdi
Street address
Neurology department, Shariati Hospital, North Kargar Street
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2224
Email
Siamak.Abdi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammadali Sahraeian
Street address
Neurology department, Shariati Hospital, North Kargar Street
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2224
Email
Siamak.Abdi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Deidentified IPD data collected for the primary and secondary outcomes will be available.
When the data will become available and for how long
Deidentified IPD data will be available 1 year after publication.
To whom data/document is available
Deidentified IPD data will be available for people working in academic institutions.
Under which criteria data/document could be used
Request coming to principal investigator, will be evaluated. Requests that are to be used in review article or meta-analysis will be accepted.
From where data/document is obtainable
Data request can reach the principal investigator through email; siamak.abdi@yahoo.com.
Phone number +989363813113 can be used for text messages.
What processes are involved for a request to access data/document
Research ethics committee certificate is needed to be enclosed in the request email. Your email will be answered within a week. If you receive no answer within a week, another email as reminder is recommended.