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IRCT20190412043248N1 IRCT 2019-06-15 Tehran University of Medical Sciences Effect of brain stimulation on the improvement of swallowing disorder in Parkinson's patients The effectiveness of combined transcranial Direct Current Stimulation (tDCS) and conventional swallowing therapy on improvement of the swallowing disorder in persons with Parkinson’s disease 2019-05-22 anticipated 20 Complete https://irct.ir/trial/38950 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment by blocks: At this stage, 20 blocks were used. Therefore, each subject by random selection of one of these blocks is placed in one of two groups. So, randomly, there will be 10 subjects in each group, Blinding description: Unawareness of the participants and the evaluator of the outcomes about the groups. N/A Parkinson. Intervention 1: Combined treatment group: Patients in this group receive anodal stimulation of tDCS with conventional treatment for 30 minutes. The anodal-tDCS with a 1 mA intensity is inserted bilaterally into the pharyngeal motor cortex in the left and right hemisphere. Conventional swallowing treatment is a protocol of rehabilitation and compensatory treatments. This protocol will be obtained according to the clinical evaluation results of swallowing. Rehabilitation treatment includes swallowing maneuvers (Mendelsohn maneuver, supraglottic swallowing maneuver, super-supraglottic swallowing maneuver, and effortful swallow ), oral-motor exercises, and Thermal-tactile stimulation. Compensatory methods will also include adjusting the volume, velocity, and speed of food delivery and postural techniques. Intervention 2: sham treatment group: In the sham-tDCS group, patients first receive tDCS stimulation for 30 seconds with an intensity of 1mA intensity, and after 30 seconds the stimulation stops and the device turns off without informing the patient. The conventional treatment is also provided to the patient simultaneously for 30 minutes. No - There is not a plan to make this available Justification or reason for not sharing IPD is To prevent plagiarism from the study data
public Aliakbar Dashtelei
Rehabilitation Faculty, Tehran University of Medical Sciences Pitch-e-Shemiran, Enghelab Ave., Tehran-IR
Tehran Iran (Islamic Republic of) 1148956111 +98 21 7762 8205 ali_dashtelei@yahoo.com Tehran University of Medical Sciences scientific Aliakbar Dashtelei
Rehabilitation Faculty, Tehran University of Medical Sciences Pitch-e-Shemiran, Enghelab Ave., Tehran-IR
Tehran Iran (Islamic Republic of) 1148956111 +98 21 7762 8205 ali_dashtelei@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Parkinson's disease with swallowing disorder Not having an implants Being patient in the On phase Age over 18 years Not having a history of dysphagia Non-pregnancy of subjects 18 years no limit Both The occurrence of any other neurological disorder (such as stroke, seizure, epilepsy, etc.) during the conduct of the research After the study begins, the implant needs to be used Do not cooperate Getting pregnant G20 Parkinson's disease Rehabilitation Rehabilitation Combined treatment group: Patients in this group receive anodal stimulation of tDCS with conventional treatment for 30 minutes. The anodal-tDCS with a 1 mA intensity is inserted bilaterally into the pharyngeal motor cortex in the left and right hemisphere. Conventional swallowing treatment is a protocol of rehabilitation and compensatory treatments. This protocol will be obtained according to the clinical evaluation results of swallowing. Rehabilitation treatment includes swallowing maneuvers (Mendelsohn maneuver, supraglottic swallowing maneuver, super-supraglottic swallowing maneuver, and effortful swallow ), oral-motor exercises, and Thermal-tactile stimulation. Compensatory methods will also include adjusting the volume, velocity, and speed of food delivery and postural techniques. sham treatment group: In the sham-tDCS group, patients first receive tDCS stimulation for 30 seconds with an intensity of 1mA intensity, and after 30 seconds the stimulation stops and the device turns off without informing the patient. The conventional treatment is also provided to the patient simultaneously for 30 minutes. Dysphagia score in aspiration-penetration scale. Timepoint: At the beginning of the sampling, after the last intervention session and one month after the last intervention session. Method of measurement: Fiberoptic endoscopic evaluation of swallowing (FEES) and aspiration-penetration scale. Dysphagia handicap index and swallowing disturbance questionnaire. Timepoint: At the beginning of the sampling, after the last intervention session and one month after the last intervention session. Method of measurement: Swallowing Disturbance Questionnaire. Dysphagia Handicap Index. Timepoint: At the beginning of the sampling, after the last intervention session and one month after the last intervention session. Method of measurement: Dysphagia Handicap Index. Tehran University of Medical Sciences Approved 2019-01-02 Ethics committee of Tehran University of Medical Sciences Rehabilitation Faculty, Tehran University of Medical Sciences Pitch-e-Shemiran, Enghelab Ave., Tehran-IR Tehran Tehran Iran (Islamic Republic of)