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Comparing Effectiveness of Transcranial direct-current stimulation (tDCS) of Dorsa Lateral Prefrontal Cortex and Mindfulness-Based Cognitive Therapy (MBCT) On Frontal lobe performance and Psychological Profile in Patients with Epilepsy Disorder.

Protocol summary

Study aim
Comparing Effectiveness of Transcranial direct-current stimulation (tDCS) of Dorsa Lateral Prefrontal Cortex and Mindfulness-Based Cognitive Therapy (MBCT) On Frontal lobe performance and Psychological Profile in Patients with Epilepsy Disorder.
Design
The clinical trial included a sham group and two experimental groups, tDCS and MBCT (parallel). Initial selection was by convenience sampling and according to entry criteria but assignment to groups was randomly.
Settings and conduct
The population consisted of all patients with epilepsy who were referred to private clinic in Urmia (Dr. somayeh Hasani Kia). The sample consisted of 45 patients with temporal lobe epilepsy who were selected by convenience sampling and assigned to two experimental and one sham groups randomly. To gather the data, first, pretest was administered. Next, tDCS and MBCT interventions were implemented to experimental groups.The sham group will receive no stimulation despite the electrodes being placed and will not participate in the MBCT classes. finally post-test will perform.
Participants/Inclusion and exclusion criteria
The most important criterion for entry into intervention are having temporal epilepsy, Not being in menstruation period, not having prosthesis in skull , not having battery in the heart, and not being pregnant. The most important criterion for entry into intervention are receiving psychological and medical interventions and medications, and any possible sensitivity to the tDCS.
Intervention groups
ّFirst group: tDCS Second group: MBCT Third group: sham
Main outcome variables
Frontal lobe function includes memory, concentration, attention, information processing, and cognitive flexibility. Psychological profiles include depression, anxiety, and stress.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190803044417N1
Registration date: 2019-09-06, 1398/06/15
Registration timing: retrospective

Last update: 2019-09-06, 1398/06/15
Update count: 0
Registration date
2019-09-06, 1398/06/15
Registrant information
Name
Shahin Azmoodeh
Name of organization / entity
Urmia University
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 1386
Email address
shahin.azmoodeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing Effectiveness of Transcranial direct-current stimulation (tDCS) of Dorsa Lateral Prefrontal Cortex and Mindfulness-Based Cognitive Therapy (MBCT) On Frontal lobe performance and Psychological Profile in Patients with Epilepsy Disorder.
Public title
Effect of Brain Stimulation and Mindfulness in treatment of Epilepsy.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Fill out the informed consent form Having temporal lobe epilepsy Age range between 15 to 50 At least be a middle school graduate Not being pregnant No prosthesis in the skull No battery in the heart Lack of psychological treatment in the past one year No other medical illnesses such as skin disease, superficial injury and fracture or infraction of skull in the stimulation area
Exclusion criteria:
Being pregnant Prior Information about Sensitivity to tDCS receiving psychological interventions and medications Receiving medical interventions for any other disorder
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Forty five patients with epilepsy who were selected by convenience sampling and assigned randomly (At first, a list of available patients was prepared randomly and then coded from 01 to 45. Using random digits table, 15 person was assigned to each group.) to two experimental and one sham groups. Each group contains of 15 patients. For random assignment we used a lottery system. In the sham group, electrodes were connected but no stimulation was applied and participants were not aware of no stimulation.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
No. 39, Entezar Ave., manzariye Street.
City
Tabriz
Province
East Azarbaijan
Postal code
5174873871
Approval date
2019-06-19, 1398/03/29
Ethics committee reference number
IR.UMSU.REC.1398.140

Health conditions studied

1

Description of health condition studied
Temporal lobe Epilepsy
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizures

Primary outcomes

1

Description
Working memory
Timepoint
tDCS group: before intervention (pre-test) and 15 days later (post-test) ,MBCT group: before intervention (pre-test) and 8 weeks later (post-test) and in the sham group, the interval between pre-test and post-test was 15 days
Method of measurement
Wechsler Scale

2

Description
Concentration
Timepoint
tDCS group: before intervention (pre-test) and 15 days later (post-test) ,MBCT group: before intervention (pre-test) and 8 weeks later (post-test) and in the sham group, the interval between pre-test and post-test was 15 days
Method of measurement
Continuous Performance Test

3

Description
Attention
Timepoint
tDCS group: before intervention (pre-test) and 15 days later (post-test) ,MBCT group: before intervention (pre-test) and 8 weeks later (post-test) and in the sham group, the interval between pre-test and post-test was 15 days
Method of measurement
Stroop test

4

Description
Cognitive Flexibility
Timepoint
tDCS group: before intervention (pre-test) and 15 days later (post-test) ,MBCT group: before intervention (pre-test) and 8 weeks later (post-test) and in the sham group, the interval between pre-test and post-test was 15 days
Method of measurement
Cognitive Flexibility Inventory

5

Description
Psychological Profile
Timepoint
tDCS group: before intervention (pre-test) and 15 days later (post-test) ,MBCT group: before intervention (pre-test) and 8 weeks later (post-test) and in the sham group, the interval between pre-test and post-test was 15 days
Method of measurement
Depression Anxiety Stress Scales -21

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: In first intervention group the tDCS applies for 20 min over the left Dorso-lateral prefrontal cortex (DLPFC), the intensity is 1.5 mA. This method was applies in the first experimental group for 10 sessions. The first 5 sessions are consecutive, and the next 5 sessions are every other day. Based on the International 10–20 system, the anodal electrode will place in the F3 region of the left hemisphere, and the cathodal electrode will place in the F4 region of the right hemisphere. After 5 daily sessions, it is better to have the next 5 sessions every other day.
Category
Rehabilitation

2

Description
Second intervention group: In the second intervention group, Mindfulness-Based Cognitive Therapy (MBCT) is administered as an 8-week program. The class time include 2-2.5 h weekly. Participants encourage to complete daily home practice for 6 days per week. The duration of home sessions are about 45 min.
Category
Rehabilitation

3

Description
Control group: The sham group will receive no stimulation despite the electrodes being placed in and will not participate in the MBCT classes.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Private clinic
Full name of responsible person
Dr. Somayeh Hasani Kia
Street address
5th floor, Hashemi Medical Complex, Hassani Street, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5719848375
Phone
+98 44 3180 1345
Email
Ja_abdeli@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Urmia
Full name of responsible person
Esmaeil Soleimani
Street address
Faculty of Literature and Humanities, Department of Psychology, Urmia University, Valfajr Blv, Seda va Sima St, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
+98 44 3375 0741
Email
soleymany.psy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Urmia
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
The University of Urmia
Full name of responsible person
Shahin Azmoodeh
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Literature and Humanities, Department of Psychology, Urmia University, Valfajr Blv, Seda va Sima St, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5719848375
Phone
+98 914 118 0435
Email
shahin.azmoodeh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Urmia
Full name of responsible person
Shahin Azmoodeh
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Literature and Humanities, Department of Psychology, Urmia University, Valfajr Blv, Seda va Sima St, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5719848375
Phone
+98 914 118 0435
Email
shahin.azmoodeh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
The university of Urmia
Full name of responsible person
shahin azmoodeh
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Literature and Humanities, Department of Psychology, Urmia University, Valfajr Blv, Seda va Sima St, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5719848375
Phone
+98 914 118 0435
Email
Shahin.azmoodeh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
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