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IRCT20190803044417N1 IRCT 2019-09-06 The University of Urmia Effect of Brain Stimulation and Mindfulness in treatment of Epilepsy. 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. 2019-06-22 anticipated 45 Complete https://irct.ir/trial/41296 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, 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. N/A Temporal lobe Epilepsy. Intervention 1: 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. Intervention 2: 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. Intervention 3: Control group: The sham group will receive no stimulation despite the electrodes being placed in and will not participate in the MBCT classes. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Shahin Azmoodeh
Faculty of Literature and Humanities, Department of Psychology, Urmia University, Valfajr Blv, Seda va Sima St, Urmia, Iran
Urmia Iran (Islamic Republic of) 5719848375 +98 914 118 0435 shahin.azmoodeh@yahoo.com The University of Urmia scientific Shahin Azmoodeh
Faculty of Literature and Humanities, Department of Psychology, Urmia University, Valfajr Blv, Seda va Sima St, Urmia, Iran
Urmia Iran (Islamic Republic of) 5719848375 +98 914 118 0435 shahin.azmoodeh@yahoo.com The University of Urmia Iran (Islamic Republic of) 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 15 years 50 years Both Being pregnant Prior Information about Sensitivity to tDCS receiving psychological interventions and medications Receiving medical interventions for any other disorder G40 Epilepsy and recurrent seizures Rehabilitation Rehabilitation Other 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. 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. Control group: The sham group will receive no stimulation despite the electrodes being placed in and will not participate in the MBCT classes. 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. 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. 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. 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. 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. The University of Urmia Approved 2019-06-19 Ethics committee of Urmia University of Medical Sciences No. 39, Entezar Ave., manzariye Street. Tabriz East Azarbaijan Iran (Islamic Republic of)