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IRCT2015100824428N1 IRCT 2016-04-01 Research Vice Chancellor of Mashhad University of Medical Sciences Assessing the effectiveness of repetitive Transcranial Magnetic Stimulation (rTMS) of the cerebellum in treatment of essential tremor. Cerebellar rTMS for essential tremor Assessing clinical effectiveness of cerebellar repetitive transcranial magnetic stimulation (rTMS) on severity of motor signs of essential tremor. 2016-05-21 anticipated 30 Complete https://irct.ir/trial/20631 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: Block randomization using sealed envelops, Blinding description: Participants: by use of sham procedure Outcome assessor: an investigator blinded to the type of intervention assessed outcome and another investigator performed data entry and analysis. N/A Essential Tremor. Intervention 1: Sham treatment (electrical stimulation of less than 3 mili amperes) using a small device located on the coil, invisible to the patient, providing 900 pulses on each cerebellar hemisphere daily for 5 days. Intervention 2: Bilateral Cerebellar rTMS using the butterfly coil providing 900 pulses on each cerebellar hemispheres daily for 5 days. Yes - There is a plan to make this available What will be shared: Data file is available along with the submitted manuscript When: Anonymized data is available open access To whom: open access Conditions: Academics might use data provided that funding sources are cited and contacted Where to obtain: contact publisher of our final manuscript How to obtain: doi:10.1016/j.brs.2019.10.003 or contact corresponding author shoeibia@mums.ac.ir Comments:
public Nahid Olfati
Department of Neurology, Ghaem Hospital, Ahmad-abad st.
Mashhad Iran (Islamic Republic of) 91766-99199 +98 51 3842 9828 olfatin@mums.ac.ir Department of Neurology, Mashhad University of Medical Sciences scientific Ali Shoeibi
Department of Neurology, Ghaem Hospital, Ahmad-abad st.
Mashhad Iran (Islamic Republic of) 91766-99199 +98 51 3842 9828 shoeibia@mums.ac.ir Department of Neurology, Mashhad University of Medical Sciences Iran (Islamic Republic of) Having a diagnosis of essential tremor (ET) based on Movement Disorder Society criteria Involvement of at least one hand Cognitively eligible to give informed consent of participation in the trial 18 years or above 18 years no limit Both Cardiac pace-maker or other implanted magnetic device or having other contraindications of performing a routine non-contrast MRI Skin defect at the occipital area preventing placement of a coil Currently pregnant or plan for pregnancy in the next 6 months History of seizure Other comorbid medical conditions capable of producing or enhancing tremor Advanced cardiac, renal, hepatic or other disabling conditions making patient physical unable to participate in examination and receiving the intervention Use of new medications with potential effect on tremor G25.0 Essential Tremor Placebo Treatment - Other Sham treatment (electrical stimulation of less than 3 mili amperes) using a small device located on the coil, invisible to the patient, providing 900 pulses on each cerebellar hemisphere daily for 5 days. Bilateral Cerebellar rTMS using the butterfly coil providing 900 pulses on each cerebellar hemispheres daily for 5 days. Tremor severity. Timepoint: At the baseline and on days 5, 12, 30 after each real or sham treatment session. Method of measurement: Fahn-Tolosa-Marin scale. NCT02704793 ClinicalTrials.gov Research Vice Chancellor of Mashhad University of Medical Sciences Approved 2015-10-07 Research Ethics Committee of Mashhad University of Medical Sciences Sakhteman-e-Ghoreishi, Daneshgah St., Research Ethics Committee Mashhad Razavi Khorasan Iran (Islamic Republic of)