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IRCT20190708044138N1 IRCT 2020-05-07 Urmia University Effect of transcranial direct current stimulation and high definition stimulation on restless leg syndrome Comparison of the effect of transcranial direct current stimulation (tDCS) and high definition stimulation (HD-tDCS) on cognitive-psychological symptoms in adults with restless leg syndrome (RLS) 2019-07-23 anticipated 45 Complete https://irct.ir/trial/40638 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be done using www.randomization.com to assign equal participants in each group (1:1 allocation ). An independent researcher will make random allocation cards using computer-generated random numbers. he will keep the original random allocation sequences until analysis time. Another independent researcher will measure the patients outcome and she will not know the allocation, Blinding description: The neuroscientist of Yazd Psychological Center will be aware of the research topic and will perform therapeutic interventions. He codes the patients and refers them to a psychologist to check the patient's mental state and record the relevant criteria based on the same code. The patients will be tested in the same condition in the neurotherapy room and the electrodes of the device will be connected to them, but they will not be aware of the real or sham stimulation. Accordingly, this study will be a double-blind study. N/A restless legs syndrome. Intervention 1: The first intervention group received transcranial direct current stimulation (HD-tDCS) at 4 mA (positive or anode stimulation) over 10 consecutive sessions (25 minutes per session). Intervention 2: The second intervention group received high definition-transcranial direct current stimulation (HD-tDCS) at 2 mA (positive or anode stimulation) over 10 consecutive sessions (25 minutes per session). Intervention 3: The first control group received high definition-transcranial direct current stimulation (HD-tDCS) with Sham over 10 consecutive sessions. Yes - There is a plan to make this available What will be shared: Participant Data File: Because the individual data of the study participants are considered, this study shares some of the data such as information about the main outcomes of the study. When: The access period starts 9 months after the results are published. To whom: The data obtained from this study are only available to researchers working at Urmia University snd Shahid Sadoughi University of Medical Sciences. Conditions: The data of this study are only permitted for correlation analysis and independent t-test. Where to obtain: Visit Mr. Mohammad Hossein Sorbi from Urmia University, or contact him by email or phone. Phone: 09131560290, Email: Sorbih@gmail.com How to obtain: Applicants are required to notify Mr. Sorbi by phone or email 9 months after the results of the study are published. Next, the data will be delivered in person. Comments:
public Mohammad Hossein Sorbi
Eleven kilometers of University Boulevard
Urmia Iran (Islamic Republic of) 5756151818 +98 44 3275 2741 sorbih@gmail.com Urmia University scientific Ali Esazadegan
Eleven kilometers of University Boulevard
Urmia Iran (Islamic Republic of) 5756151818 009832752741 a.esazade@gmail.com Urmia University Iran (Islamic Republic of) Iran (Islamic Republic of) Diagnosis of restless legs syndrome by a psychiatrist or psychologist Gaining moderate to high score in severity of the syndrome (scores of 5 to 12) in the international restless legs syndrome questionnaire Rejecting differential diagnosis of neuro-motor disorder by a neurologist and absence of neurological disorder Aged between 18 to 75 years Not suffering from cardiovascular disease, kidney disease and diabetes (getting information by asking from participants and get help from a physician) Not Smoking and not taking painkillers, sedatives and hypnotics Non-pregnancy in women 18 years 75 months Both Dissatisfaction to participate in the research Having a type of motor or cognitive disabilities that interferes working with computer Receiving simultaneous psychiatric treatment or other psychotherapies to relieve RLS symptoms History of seizure disorders in individuals, having a pacemaker, having a metal object in the head and neck or any other obstacle to do electrical stimulation G25.81 Restless legs syndrome Treatment - Devices Treatment - Devices Placebo The first intervention group received transcranial direct current stimulation (HD-tDCS) at 4 mA (positive or anode stimulation) over 10 consecutive sessions (25 minutes per session). The second intervention group received high definition-transcranial direct current stimulation (HD-tDCS) at 2 mA (positive or anode stimulation) over 10 consecutive sessions (25 minutes per session). The first control group received high definition-transcranial direct current stimulation (HD-tDCS) with Sham over 10 consecutive sessions. Cognitive Symptoms. Timepoint: Cognitive Symptoms was measured at the beginning of the study (before the intervention), after the last treatment session, and 30 days (one month) after the last treatment session. Method of measurement: The Integrated Visual and Auditory (IVA-2). Depression. Timepoint: Depression was measured at the beginning of the study (before the intervention), after the last treatment session, and 30 days (one month) after the last treatment session. Method of measurement: beck depression inventory (BDI-II). Severity of Restless Legs Syndrome. Timepoint: Severity of Restless Legs Syndrome was measured at the beginning of the study (before the intervention), after the last treatment session, and 30 days (one month) after the last treatment session. Method of measurement: International Restless Legs Syndrome Questionnaire. Urmia University Approved 2019-06-25 Ethics committee of Shahid Sadoughi University of Medical Sciences Central Administration, Bahonar Sq., Yazd Yazd Yazd Iran (Islamic Republic of)