study the Transcranial Direct Current Stimulation (TDCS) on treatment-resistant parasitic epilepsy attacks in 6-16 years old childeren
Design
Clinical trial with control and intervention group of 10 person in each group, community based and pragmatic, in parallel, double-blind and randomized with a table
Settings and conduct
The study was conducted double blind and patients from the Ghaem Hospital have been enrolled. Throughout the study, anti-epileptic drugs that the child consumes prior entering the study continues , without any interactions with the amount and type of drug they used befor as in the absence of any effect of this method, more recurrence of attacks would not be occured.
Participants/Inclusion and exclusion criteria
Patients with temporal lobe epilepsy and resistant seizures to medical treatment according to neurologist confirmation and parental satisfaction
Intervention groups
In the Intervention group treatment resistant epilepsy Patients in this group will be Transcranial Direct Current stimulated from the skull for 20 minutes once a day for 5 consecutive days and in the control group, the electrodes will be only put on the head and after 10 seconds when the heat created it will be turned off
Main outcome variables
The number of epileptic waves in the EEG
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161230031668N2
Registration date:2018-08-04, 1397/05/13
Registration timing:registered_while_recruiting
Last update:2018-08-04, 1397/05/13
Update count:0
Registration date
2018-08-04, 1397/05/13
Registrant information
Name
farah ashrafzadeh
Name of organization / entity
Mashhad University of Medical Seinces
Country
Iran (Islamic Republic of)
Phone
+98 51 3842 4834
Email address
ashrafzadehf@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-01, 1396/12/10
Expected recruitment end date
2018-09-01, 1397/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
study the Transcranial Direct Current Stimulation(TDCS) on treatment-resistant parasitic epilepsy attacks
Public title
Study the effect of brain electrical stimulation on epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient consent
Diagnosis of temporal lobe epilepsy based on clinical symptoms and evidence of a brain barrier by a neurologist
Treatment resistant seizures
Exclusion criteria:
Age
From 6 years old to 16 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using the numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was performed with full satisfaction of the parents of the patient, while the patient and the investigator do not know which of the participants are in the intervention group or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ghoreishi building, Daneshgah AVE
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Approval date
2018-01-31, 1396/11/11
Ethics committee reference number
IR.MUMS.fm.REC.1396.666
Health conditions studied
1
Description of health condition studied
Epilepsy
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizures
Primary outcomes
1
Description
The number of epileptic waves in the EEG
Timepoint
At the beginning of the study and 7 days after the end of intervention
Method of measurement
NIHON KOHDEN EEG-1200 EEG machine models related to Andisheh company
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment resistant epilepsy Patients in this group will be Transcranial Direct Current stimulated from the skull for 20 minutes once a day for 5 consecutive days.
Category
Treatment - Devices
2
Description
Control group: In the control group, the electrodes will be only put on the head and after 10 seconds when the heat created it will be turned off
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Farah Ashrafzadeh
Street address
Ahmad abad AVE, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3801 2753
Email
ashrafzadehf@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghoreishi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3841 1538
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Narges Hashemi
Position
Non-faculty specialist
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Ahmadabad AVE Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3801 2753
Email
hashemin553@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farah Ashrafzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ahmad abad AVE, Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 32753
Email
ashrafzadehf@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farah Ashrafzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Ahmadabad AVE Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+51 38012753
Email
ashrafzadehf@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available