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IRCT20170808035562N2 IRCT 2018-06-16 Tehran University of Medical Sciences ٍEffect of transcranial direct current stimulation on drug craving of addicts tDCS Assessment of the effect of transcranial direct current stimulation on drug cue-induced craving in abstinent methamphetamine users using a visual paradigm and its prediction using resting state EEG signals 2018-06-22 anticipated 60 Complete https://irct.ir/trial/26834 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Participants randomly undergo one active or sham tDCS session. The randomization procedure will be performed by Matlab software. A binary randome sequence with length 60 will be generated, Blinding description: We will use STARSTIM for electrical brain stimulation located in National Brain Mapping Laboratory (NBML). This device has the capability to assign codes to different stimulation states (active and sham). One of NBML staffs who is not engaged in our project will select this codes. Participants, investigator, and data analyzer are uninformed that which code is related to sham or active states. N/A Methamphetamine dependence disorder. Intervention 1: Intervention group: Direct current will be delivered using a StarStimtCS system and transferred by a pair of circular stimulation electrodes with 1 cm radius. They have rear-fill apertures allows for gel supply. Anode/cathode electrodes will respectively be placed over F3 and F4 electrodes (EEG 10/20 system) to target the right and left dorsolateral prefrontal cortex (rDLPFC). During anodal tDCS, a 2 mA current will be applied for 20 min. Intervention 2: Control group: StarStimtِCS system with a pair of circular stimulation electrodes with 1 cm radius will be used. Anode/cathode electrodes will respectively be placed over F3 and F4 electrodes (EEG 10/20 system). The simulator will be turned off after a gradual ramping up of electrical current to 2 mA and down to 0 mA which took 1 min. The electrodes will be on the scalp for the remaining 18 min and subjects will not be informed that the device is turned off. َAfter that, there will be again a gradual ramping up of electrical current to 2 mA and down to 0 mA which took 1 min. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Hassan Khajehpour
No.1, Shahid borhani Alley.Kargar Shomali Ave, Enghelab Squ
Tehran Iran (Islamic Republic of) 1417933331 +98 21 6695 3144 h-khajehpoor@razi.tums.ac.ir Tehran University of Medical Sciences scientific Bahador Makkiabadi
Medical Physics and Biomedical Engineering Department,Medical School, Tehran University of Medical Sciences, 16 Azar Ave, Pursina Ave, Tehran
Tehran Iran (Islamic Republic of) 1417933331 +98 21 6646 6383 b-makkiabadi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Male gender Age ≥18 and <61 years old Farsi speaking Diagnosed with Methamphetamine Use Disorder (last 12 months) based on Structured Clinical Interview for DSM-5 (SCID-5) Abstinent from any drugs except cigarettes for at least one week based on medical records or self-report, confirmed by urine analysis Positive response to Methamphetamine cue-reactivity screening (MCS) Willing and capable of interacting with the informed consent process8. The ability to understand, read and answer the tests 18 years 61 years Male Unwillingness or inability to complete any of the major aspects of the study protocol, including drug cue rating, or behavioral assessment. Abstinence from methamphetamine for more than 6 months based on self-report Any major clinical psychiatric disorder, assessed by Structured Clinical Interview for DSM-5 (SCID-5) Active suicidal ideation with intent or plan determined by self-report or assessment by PI or study staff during the initial screening or any other phase of the study Positive drug test for amphetamines, opioids, cannabis confirmed by urine tests Any active skin disorder that affects skin integrity of the scalp Having any condition that would preclude undergoing a tDCS stimulation based on the tDCS safety checklist Unstable medical disorder reported in subject’s medical history or by a clinician assessment History of major head trauma, seizure, brain surgery, intracranial metal implantation Non-correctable vision or hearing problems. F11.2 Opioid dependence Treatment - Devices Treatment - Devices Intervention group: Direct current will be delivered using a StarStimtCS system and transferred by a pair of circular stimulation electrodes with 1 cm radius. They have rear-fill apertures allows for gel supply. Anode/cathode electrodes will respectively be placed over F3 and F4 electrodes (EEG 10/20 system) to target the right and left dorsolateral prefrontal cortex (rDLPFC). During anodal tDCS, a 2 mA current will be applied for 20 min. Control group: StarStimtِCS system with a pair of circular stimulation electrodes with 1 cm radius will be used. Anode/cathode electrodes will respectively be placed over F3 and F4 electrodes (EEG 10/20 system). The simulator will be turned off after a gradual ramping up of electrical current to 2 mA and down to 0 mA which took 1 min. The electrodes will be on the scalp for the remaining 18 min and subjects will not be informed that the device is turned off. َAfter that, there will be again a gradual ramping up of electrical current to 2 mA and down to 0 mA which took 1 min. Amplitude of event-related potentials with middle latency (P3). Timepoint: Immediately before and after intervention. Method of measurement: Event-related potentials will be recorded using a bio-signal amplifier with CE & FDA approval (g.HIamp, g.tec company ) from 62 scalp sites. Amplitude of event-related potentials with late latency (LPP). Timepoint: Immediately before and after intervention. Method of measurement: Event-related potentials will be recorded using a bio-signal amplifier with CE & FDA approval (g.HIamp, g.tec company ) from 62 scalp sites. Amplitude of event-related potentials with early latency (<300 ms). Timepoint: Immediately before and after intervention. Method of measurement: Event-related potentials will be recorded using a bio-signal amplifier with CE & FDA approval (g.HIamp, g.tec company ) from 62 scalp sites. Functional brain connectivity. Timepoint: Before intervention-after intervention. Method of measurement: Weighted Phase Lag Index. Effective brain connectivity. Timepoint: Before intervention-after intervention. Method of measurement: Granger causality method. ٍelectric neuronal activities. Timepoint: Before intervention-after intervention. Method of measurement: Source reconstruction methods such as Standardized low-resolution brain electromagnetic tomography (sLORETA). Craving for Methamphetamin. Timepoint: Before, during & after. Method of measurement: Visual Analogue Scale (VAS). Craving for Methamphetamine. Timepoint: Before & after. Method of measurement: Desire for Drug Questionnaire. Depression. Timepoint: After intervention. Method of measurement: Depression Anxiety and Stress Scale (DASS). Impulsivity. Timepoint: After Intervention. Method of measurement: Barratt Impulsiveness Scale. Positive & Negative Affect. Timepoint: Before and After Intervention. Method of measurement: Positive and Negative Affect Scale. Anxiety. Timepoint: After Intervention. Method of measurement: Depression Anxiety and Stress Scale (DASS). Stress. Timepoint: َبفثق هدفثقرثدفهخد. Method of measurement: Depression Anxiety and Stress Scale (DASS). Tehran University of Medical Sciences Approved 2016-08-22 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences , Pursina St, District 6, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)