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IRCT20230504058069N1 IRCT 2023-06-18 Mashhad University of Medical Sciences ًRTMS effects on PSP patients Effect of repetitive transcranial magnetic stimulation on dysarthria and postural disturbance in patients with progressive supranuclear palsy 2023-05-26 anticipated 12 Complete https://irct.ir/trial/70086 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: there was used randominaztion techniques by blocks for patients' groups randominazation, for this purpose we must make a block by 30 charachters with combination of A ,B alphabet in "sealed envelope" site and use it for randominazation. we use allocation concealment by sealed envelops, Blinding description: blinding was done in participant patients,investigators and outcome assesors.patients and investigators by using a secret code in the selead envelopes remain blinded and information analizer is chosen from out of researcher group Intervention patient (receive RTMS or sham) in sealed envelopes that code are received. Coding by one of the project collaborators It takes place and the doctor, evaluator and patient are blinded. N/A PSP Proressive supranuclear palsy. Intervention 1: Intervention group: 6 PSP patients who receive 10 sessions of rTMS with 900 daily pulses of 10 Hz every other day. The location of the coils will be in contact with the skull two centimeters on the sides and one centimeter below the inion. Intervention 2: Control group: 6 PSP patients who receive 10 sessions of rTMS every other day ,along with a 3 cm non-conductive object between the scalp and the cap of the device and 900 daily pulses of 10 Hz. The location of the coils will be in contact with the skull two centimeters on the sides and one centimeter below the inion. Yes - There is a plan to make this available What will be shared: All the potential data of movement score and questionnaires and speech and swallowing scores of patients can be shared after making them non-identifiable When: Access starts 6 months to a year after publication To whom: only available for people working in academic institutions Conditions: It is possible to use the documents of this research only by mentioning the names of its researchers in articles and academic researches. Where to obtain: from responsible author: Mina Farah Nejad Email: m.farahnezhad@yahoo.com and farahnezhadm991@mums.ac.ir Phone number: 00989127635742 How to obtain: After requesting to receive the research documents by the researcher's academic email and after explaining about the research and the reason for the need of the desired documents by sending to the responsible author's email, if accepted, it will be sent within 1 month at the latest Comments:
public Mina FarahNezhad
Unit 303,Eastern Wing, Third Floor,Tower G, Tower G4,before Kharazi Highway,Northern Pazhouhesh Blvd,Chitgar,Tehran
mashhad Iran (Islamic Republic of) 1496960720 +98 912 763 5742 m.farahnezhad@yahoo.com Mashhad University of Medical Sciences scientific mina farahnezhad
Unit 303, Third Floor,Eastern Wing,Tower G4,G Towers,before Kharazi Highway,Northern pazhouhesh Blvd.,Chitgar,Tehran
mashhad Iran (Islamic Republic of) 1496960720 +98 912 763 5742 m.farahnezhad@yahoo.com Mashhad University of Medical Sciences Iran (Islamic Republic of) PSP patients that was diagnosed by national institute of neurologic disease and stroke for PSP citeria patient who can stand alon and without helping patient who can walking at least a few steps without helping patient who can speak and answer the questions patient who has signed the informed consent form to enter the plan no limit no limit Both patient who was diagnosed dementia by DSM-IV criteria patient who had vestibular or properioception or sensory deficits patient who has any contraindication of brain stimulation (such as pacemakers or presence of metal objects in the head) the patient had dysartheria before the onset of disease patient who had past medical history of stroke patient who is mute G23.1 Progressive supranuclear ophthalmoplegia [Steele-Richardson-Olszewski] Rehabilitation Placebo Intervention group: 6 PSP patients who receive 10 sessions of rTMS with 900 daily pulses of 10 Hz every other day. The location of the coils will be in contact with the skull two centimeters on the sides and one centimeter below the inion Control group: 6 PSP patients who receive 10 sessions of rTMS every other day ,along with a 3 cm non-conductive object between the scalp and the cap of the device and 900 daily pulses of 10 Hz. The location of the coils will be in contact with the skull two centimeters on the sides and one centimeter below the inion. Checking the postural instabilility of patients. Timepoint: The beginning of the study (before starting rTMS), the end of receiving rTMS, four months later. Method of measurement: Kinematic analysis of scoring movement based on the results of forces and energy. Checking the speech and swalling of patients. Timepoint: The beginning of the study (before starting rTMS), the end of receiving rTMS, four months later. Method of measurement: Wanberg's auditory-perceptual assessment index and the Northwestern swallowing disorder test. کیفیت زندگی بیماران. Timepoint: The beginning of the study and the end of the study. Method of measurement: PDQL questionnaire. Mashhad University of Medical Sciences Approved 2022-11-08 Research Ethics committees of school of medicine-Mashhad university of medical sciences Research and Technology Vice-Chancellor, Qurashi Building, next to Hoize Cinema,University St.,Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)