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IRCT20121110011424N6 IRCT 2024-05-08 Tehran University of Medical Sciences Effect of auricular vagus nerve stimulation in Parkinson disease and freezing of Gait Investigating the Effect of auricular vagus nerve stimulation on Target Gait improvement in patients with Parkinson disease and freezing of Gait 2024-06-19 anticipated 54 Complete https://irct.ir/trial/76377 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were divided into 2 groups with sequentially numbered method( randomization with the random number builder software), Blinding description: 1. Blinding of the patient: the patient will not know whether he will receive the stimulation or not. 2. Gait Analyzer: He will not know that the patient has received stimulation or the sham procedure. Only the investigator will know that the patient received stimulation or sham procedure. N/A Parkinson's disease. Intervention 1: Intervention group: Stimulation of the vagal branch of the ear (location of two electrodes: 1. right ear concha, 2. patient's shoulder (in the form of a pad-like plate)) with a frequency of 20 Hz and electric current adjusted according to the patient's tolerance and for two weeks once a day Once in the morning and the next time in the evening, by patient at home for 20 minutes each time. Intervention 2: Control group: Sham intervention without receiving electric current (location of two electrodes: 1. right ear concha, 2. patient's shoulder (in the form of a pad-like plate)) for two weeks twice a day, once in the morning and the next time in the evening, by Self-care at home for 20 minutes each time. Yes - There is a plan to make this available What will be shared: Clinical and demographic data will be available When: When data was published To whom: Public Conditions: For scientific use only Where to obtain: From principal investigator Email Dr. Abbas Tafakhori E-mail: a_tafakhori@sina.tums.ac.ir How to obtain: PI approval Comments:
public Reza Samiee
No.1, Iranika apartment, 6th Nobakht Ave, Nobakht St
Gorgan Iran (Islamic Republic of) 4915659687 +98 17 3232 4159 Rezasamieepgh@gmail.com Tehran University of Medical Sciences scientific Abbas Tafakhori
Neurology research center, Imam Khomeini Hospital Complex, Keshavarz Blvd, Tehran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 0000 Abbas.tafakhori@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Hoehn & Yahr index between 2-3 able to walk 30 meters without help Has been treated with a stable dose of dopaminergic drugs in the last two months Able to follow simple verbal commands The patient can turn 180 degrees at one point The age of patients should be less than 76 years. The Montreal cognitive assessment index should be less than 21. 18 years 75 years Both Presence of specific musculoskeletal disorders Heart problems, especially arrhythmias and having a pacemaker History of stroke and myocardial infarction Diabetes and neuropathy The presence of cognitive, vision and breathing problems that affect the performance of tasks Neurological disorders other than Parkinson's Surgery that affects the movement of patients. The patient needs assistance to walk. Body mass index above 30 A history of receiving vagus nerve stimulation Taking anticholinergic drugs or cholinesterase inhibitors Freezing of Gait for reasons other than Parkinson's G20 Parkinson's disease Treatment - Devices Treatment - Devices Intervention group: Stimulation of the vagal branch of the ear (location of two electrodes: 1. right ear concha, 2. patient's shoulder (in the form of a pad-like plate)) with a frequency of 20 Hz and electric current adjusted according to the patient's tolerance and for two weeks once a day Once in the morning and the next time in the evening, by patient at home for 20 minutes each time Control group: Sham intervention without receiving electric current (location of two electrodes: 1. right ear concha, 2. patient's shoulder (in the form of a pad-like plate)) for two weeks twice a day, once in the morning and the next time in the evening, by Self-care at home for 20 minutes each time The improvement of movements and gait problems of parkinsonian patients with freezing. Timepoint: Before intervention and 2 weeks after intervention. Method of measurement: Gate analysis with force plate and motion analyzer and MDS-UPDRS questionnaire. Adverse effect. Timepoint: 2 weeks after intervention. Method of measurement: Adverse effect form. Tehran University of Medical Sciences Approved 2024-03-10 Ethics committee of Tehran University of Medical Sciences Qods Avenue, Tehran Tehran Tehran Iran (Islamic Republic of)