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IRCT20190708044138N2 IRCT 2020-05-18 Shiraz University of Medical Sciences Effectiveness of High Definition-transcranial Direct Current Stimulation (HD-tDCS) on the mental health of elderly Effectiveness of High Definition-transcranial Direct Current Stimulation (HD-tDCS) on Cognitive Problems and Mood of Shiraz Elderly 2019-11-12 anticipated 30 Complete https://irct.ir/trial/47724 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 researcher will measure the patients outcome and he will not know the allocation, Blinding description: The neuroscientist of geriatric research 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 their, but they will not be aware of the real or sham stimulation. Accordingly, this study will be a double-blind study. N/A Major depressive disorder, single episode, moderate. Intervention 1: The 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 2: The control group received high definition-transcranial direct current stimulation (HD-tDCS) with sham mode 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 Shiraz University of Medical Sciences. Conditions: The data of this research are only permitted for review and meta-analysis studies. 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 submit a written request to Mr. Sorbi by email (9 months after the publication of the research results). After reviewing the request, the data will be sent to the applicant online via email. 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 Mohammad Ali Nazarinia
Zand St, Shiraz Geriatric Research Center
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3212 2283 nazariniam@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Gaining mild to moderate depression score (scores from 14to 30) in the Beck depression inventory Rejecting differential diagnosis of neuro-motor disorder by a neurologist and absence of neurological disorder Aged between 50 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. 50 years 75 years 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 depression disorder 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 F32.1 Major depressive disorder, single episode, moderate Treatment - Devices Placebo The 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 control group received high definition-transcranial direct current stimulation (HD-tDCS) with sham mode 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). Shiraz University of Medical Sciences Approved 2019-08-07 Ethics committee of Shiraz University of Medical Sciences Zand St, Central building of Shiraz University of Medical Sciences, Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)