]>
IRCT20200225046611N1 IRCT 2020-04-01 Tehran University of Medical Sciences Repetitive transcranial magnetic stimulation in psychological non-epileptic seizure rTMS in PNES Evaluation of the efficacy of repetitive transcranial magnetic stimulation in the treatment of patients with functional neurological symptoms (psychological non-epileptic seizure subtype) 2020-04-05 anticipated 30 Complete https://irct.ir/trial/46232 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: block randomization Randomization unit: individual Randomization instrument: random allocation software Random sequences using quadratic blocks Allocation concealment with software, Blinding description: After examining the inclusion and exclusion criteria, the researcher will refer patients to the rTMS unit. In this unit by the therapist, referral patients are divided into two groups of test and control using random numbers. Some receive rTMS treatment and some sham TMS. Intervention in control group designed the same as real treatment that means the patient is in a chair and the coil is placed on his head but magnetism wouldn't used. The evaluator who asks the patient the questionnaire questions before and after the intervention and the data analyzer will not know which patients are in the test or control group. N/A Functional neurological symptom disorder (Psychogenic non-epileptic seizure subtype). Intervention 1: Intervention group: Stimulation with rTMS Variant 2 from NEROSOFT Russia company by 10 Hz frequency, 12 sessions for one month, 25 minutes per session, 1200 stimulations per day, with appropriate stimulation threshold for each individual using eight coils and over The right temporo-parietal junction will be performed. Intervention 2: Control group: patients in this group sit on the rTMS chair for 12 months for 25 minutes but do not receive any magnetic stimulation.After completion of the study, the group will receive routine treatment if symptoms persist. Yes - There is a plan to make this available What will be shared: patients' data can be shared after unidentifiable and deleted names When: Access will begin 6 months after the results are published To whom: Data will be available only to researchers working in academic and scientific centers. Conditions: Documentation is only available for meta-analysis studies Where to obtain: Access information on request at arbabimo@tums.ac.ir How to obtain: Applicants must identify their scientific and academic identities and clearly state their intention to request information for use in meta-analytic research. Comments:
public Mohammad Arbabi
Imam Khomeini Hospital Complex,Tehran Province ,Tehran Chamran, East, Highway, Baqerkhan St
Tehran Iran (Islamic Republic of) 14119733141 +98 21 6119 2421 arbabimo@tums.ac.ir Tehran University of Medical Sciences scientific Mohammad Arbabi
Imam Khomeini Hospital Complex,Tehran Province ,Tehran Chamran, East, Highway, Baqerkhan St
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2421 arbabimo@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years old with psychological non-epileptic seizure based on DSM5 18 years no limit Both True seizure or epileptiform changes in electroencephalographic long term monitoring Suicide thought Use of Lowering seizure threshold drugs Risk of new suicide attempt Psychosis Personal or family history of seizure Metal objects within 30 cm of the coil such as: aneurysm clips, cervical or cerebral stents, cardiac pacemaker or defibrillators, cochlear implants, Face tattoo using magnetic field sensitive ink F44.4 Conversion disorder with motor symptom or deficit Treatment - Devices Treatment - Devices Intervention group: Stimulation with rTMS Variant 2 from NEROSOFT Russia company by 10 Hz frequency, 12 sessions for one month, 25 minutes per session, 1200 stimulations per day, with appropriate stimulation threshold for each individual using eight coils and over The right temporo-parietal junction will be performed. Control group: patients in this group sit on the rTMS chair for 12 months for 25 minutes but do not receive any magnetic stimulation.After completion of the study, the group will receive routine treatment if symptoms persist. Psychological non-epileptic seizures severity. Timepoint: At the beginning of the study (before the intervention), immediately after the intervention and two months later. Method of measurement: Clinical Global Impression. Depressive severity. Timepoint: At the beginning of study(before intervention), immediately after intervention and two months later. Method of measurement: Beck's depression inventory. Quality of life. Timepoint: At the beginning of study(before intervention), immediately after intervention and two months later. Method of measurement: WHO Quality of Life-BREF. nimad Approved 2020-02-05 Ethics committee of Tehran University of Medical Sciences Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)