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IRCT20230125057225N1 IRCT 2023-02-01 Semnan University of Medical Sciences Effect of rTMS device in improving walking in patients with Parkinson's disease EROSDIGPD Effect of Repetitive Transcranial Magnetic Stimulation over the supplementary motor area and dorsolateral prefrontal cortex in improvement of gait in Parkinson’s disease 2023-02-09 anticipated 21 Complete https://irct.ir/trial/68280 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Supportive, Other design features: In the study, we have 3 groups in which the same treatment (rTMS) is applied in 2 groups and we have a control group in which the rTMS device is applied off, Randomization description: Simple randomization method Randomization unit: individual Randomization tool: sealed envelope We write the numbers 1 to 21 on each paper and then each envelope is assigned to one person by lottery, and the numbers 1-4-7...are assigned to the first group, and the numbers 8-2-5-8...are assigned to the second group, and the numbers 9-3-6... They belong to the third group, Blinding description: The patients in the study are blinded and do not know which group they are in. In the 2 treatment groups, the device is turned on, and in the control group, the device is turned off during rTMS application. The clinical caregiver is also blind in the study because he does not know about our grouping and he is only told for which patients to turn on the device and for which patients to turn off the device. N/A Parkinson's disease. Intervention 1: Intervention group:The intervention is by rTMS device made by Madinatab Iran company and the evaluation is done by three dimensional motion analysis device and by Qualysis software and the intervention by rTMS device is in the form of 10 therapy sessions (3 sessions per week and 4 sessions at the end of the week) which is applied in the SMA group with a frequency of 10Hz in the M1 area with a pulse count of 2000 and a resting motor threshold intensity of 90%. Intervention 2: Intervention group:The intervention is by rTMS device made by Madinatab Iran and the evaluation is done by three dimensional motion analysis device and Qualysis software and the intervention by rTMS device is 10 treatment sessions (3 sessions per week and 4 sessions at the end of the week) which is applied in the DLPFC group with a frequency of 10 Hz in the F3 area with a pulse count of 2000 and a resting motor threshold intensity of 90%. Intervention 3: Control group: In the control group, the rTMS device is placed silently on the patients' heads so that the patients can use the visual and sensory feedback to receive the placebo treatment, and the patients' gait is evaluated before and after and as a 1-month follow-up by a three-dimensional motion analysis device and by the Qualysis software. Yes - There is a plan to make this available What will be shared: People's information, including age and gender, can be published, but the names of people cannot be published When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Data must be used confidentially Where to obtain: aliheidarinejad7444@gmail.com Ali heidarinejad 00989129345778 How to obtain: After giving an email or a phone call to the mentioned phone number, the documents will reach her within 3 weeks Comments:
public Ali Heidarinejad
Ferdous Blvd, west of North Bahar St., West Manouchehri St., 1 Acacia Alley, No. 13, Zang 8
Tehran Iran (Islamic Republic of) 1484765733 +98 21 4494 4265 aliheidarinejad7444@gmail.com Semnan University of Medical Sciences scientific Ali heidarinejad
Ferdous Blvd, west of North Bahar St., West Manochehri St., 1 Acacia Alley, No. 13, Zang 8
Tehran Iran (Islamic Republic of) 1484765733 0092144944265 aliheidarinejad7444@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Patients with advanced Parkinson's (patients who are in advanced stages often have movement problems - incontinence - insomnia and dementia) People with Parkinson's disease have freezing of gait (FOG). People with Parkinson's who take L-Dopa People who are over 45 years old (according to the opinion of the neurologist who advised the article) The patient should be able to walk without crutches 45 years no limit Both Associated painful conditions that may distort the clinical picture of the study People who have a history of epilepsy and have a history of taking antiepileptic drugs such as benzodiazepines. People with a history of cerebral hemorrhage People who have problems such as brain aneurysm or brain plaque People with dementia Based on the Bech questionnaire, patients with major depression are excluded from the study G20 Parkinson's disease Rehabilitation Rehabilitation Rehabilitation Intervention group:The intervention is by rTMS device made by Madinatab Iran company and the evaluation is done by three dimensional motion analysis device and by Qualysis software and the intervention by rTMS device is in the form of 10 therapy sessions (3 sessions per week and 4 sessions at the end of the week) which is applied in the SMA group with a frequency of 10Hz in the M1 area with a pulse count of 2000 and a resting motor threshold intensity of 90%. Intervention group:The intervention is by rTMS device made by Madinatab Iran and the evaluation is done by three dimensional motion analysis device and Qualysis software and the intervention by rTMS device is 10 treatment sessions (3 sessions per week and 4 sessions at the end of the week) which is applied in the DLPFC group with a frequency of 10 Hz in the F3 area with a pulse count of 2000 and a resting motor threshold intensity of 90%. Control group: In the control group, the rTMS device is placed silently on the patients' heads so that the patients can use the visual and sensory feedback to receive the placebo treatment, and the patients' gait is evaluated before and after and as a 1-month follow-up by a three-dimensional motion analysis device and by the Qualysis software. 1- The variable of hip-knee-ankle joint movement angles which is measured by the motion device. Timepoint: Before starting the intervention - the end of 10 treatment sessions -1month follow-up. Method of measurement: three dimensional motion analysis device. The variable of the movement score which is measured by the UPDRS-part 3 questionnaire. Timepoint: Before starting the intervention - the end of 10 treatment sessions -1month follow-up. Method of measurement: Questionnaire UPDRS-part 3. Semnan University of Medical Sciences Approved 2023-01-24 Ethics Committee of Semnan University of Medical Sciences West Ferdous Blvd., Bahrashmali St., West Manochehri St., 1 Acacia Alley, No. 13, Zang 8 Tehran Tehran Iran (Islamic Republic of)