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IRCT20230430058029N1 IRCT 2023-05-29 Rasht University of Medical Sciences Evaluation of the effectiveness of transcranial direct current stimulation (tDCS) in patients with substance abuse Evaluation of the effectiveness of transcranial direct current stimulation (tDCS) on the level of craving and quality of life of patients with substance-use disorders 2023-06-19 anticipated 60 Complete https://irct.ir/trial/69873 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Other design features: Due to the chronicity of substance dependence, the high cost of tDCS treatment and also the benefit of more participants from this treatment, a cross-sectional design will be used in this study. Participants in this project will be divided into three groups of 20 people using block randomization method. The first and second groups will be cross-checked on tDCS treatment and Sham control. In the first 15 sessions, the first group is treated daily by cathodic tDCS and the second group is controlled by Sham. In the next 15 sessions, the two groups will be replaced. The third group will only be subject to standard treatment.Active treatment of brain stimulation according to the tDCS protocol of cathedral type is done in daily sessions, each session for 30 minutes for fifteen days. Each time a tDCS is performed (before and after each session), the patient is evaluated for any side effects. Assessment of side effects in it is performed based on a self-made questionnaire (made by the research center and supervised by 5 collaborating specialists). After the initial treatment, for three months on a weekly basis, all three groups receive standard matrix psychotherapy and 6 sessions of relaxation training. During the follow-up period, patients will be evaluated for substance use in three stages of 1 month, 3 months and 6 months. Examining substance use in matrix treatment sessions will be random.Brain stimulation through electrical current is a widespread applied technology for cerebral diseases.In the present study, for brain stimulation, we used TDCS device that was devised by Paym-e Gilan Mehr (knowledge‑based company in Iran). The source of current is 18 V alkaline batteries with dimention about 32 cm × 21 cm × 11 cm; its weight is 5.1 kg In this study, 3 cathode leads and 3 anode leads are used. Each probe has two poles, positive and negative(3 cathode probes and 3 anode probes) has a cross-sectional area of 4 cm and a coating of rubber material is drawn on it, which easily transfers the current to the surface of the skull by the gel. The probes are placed side by side.Find that the cathodal leads are connected to each other without connecting to each other and in a triangular manner with the base downwards in the supraorbital regions of the right and fp2 in the EEG 10-20 system and the anodal leads in the left temporal-occipital region.(P1-C3- T7) is placed in the form of a triangle whose vertex is upwards and the base is outwards and downwards. The anode probes are placed slightly below the said level (limbic area of the brain).The electrodes are non-metallic and conductive and, after being impregnated with normal saline, are held in place by an elastic band in the scalp to facilitate transmission and reduce irritation in the skin area. After ensuring the placement of the electrodes, the tDCS device, which can be charged with an 18-volt battery, supplies direct and uniform direct current (up to 2 mA to each of the 3 electrodes) through the electrodes to the cortex below the electrode for a maximum of 30 minutes. Sends. Films and music are also used during the 30 minutes of treatment to help calm patients, Randomization description: Participants will be divided into three groups of 20 people using the block randomization method with a size of 6. The randomization unit is individual and generates sequences through the site "sealed envelope (https://www.sealedenvelope.com/simple-randomiser/v1/lists)" Will be achieved. Allocation concealment will be done through a sealed envelope. 3 Condition 1: substance use disorder. Condition 2: Other stimulant dependence. Intervention 1: The first intervention group is treated daily with cathodic TDCS method in the first 15 sessions, and after 5 days of rest, they are treated with Sham in the next 15 sessions.Active treatment of brain stimulation according to the tDCS protocol of cathedral type is done in daily sessions, each session for 30 minutes for fifteen days. Each time a tDCS is performed (before and after each session), the patient is evaluated for any side effects.Sham treatment is in such a way that the probes are placed on the head of the patients, but the electric current is not connected to it. Films and music are also used during the 30 minutes of tDCS and Sham treatment to help calm patients. After initial treatment, for 6 months, all three groups receive standard matrix psychotherapy and 6 sessions of relaxation training weekly. In the present study, for brain stimulation, we used TDCS device that was devised by Paym-e Gilan Mehr (knowledge‑based company in Iran). The source of current is 18 V alkaline batteries with dimention about 32 cm × 21 cm × 11 cm; its weight is 5.1 kg In this study, 3 cathode leads and 3 anode leads are used. Each probe has two poles, positive and negative(3 cathode probes and 3 anode probes) has a cross-sectional area of 4 cm and a coating of rubber material is drawn on it, which easily transfers the current to the surface of the skull by the gel. The probes are placed side by side.Find that the cathodal leads are connected to each other without connecting to each other and in a triangular manner with the base downwards in the supraorbital regions of the right and fp2 in the EEG 10-20 system and the anodal leads in the left temporal-occipital region.(P1-C3- T7) is placed in the form of a triangle whose vertex is upwards and the base is outwards and downwards. The anode probes are placed slightly below the said level (limbic area of the brain).The electrodes are non-metallic and conductive and, after being impregnated with normal saline, are held in place by an elastic band in the scalp to facilitate transmission and reduce irritation in the skin area. After ensuring the placement of the electrodes, the tDCS device, which can be charged with an 18-volt battery, supplies direct and uniform direct current (up to 2 mA to each of the 3 electrodes) through the electrodes to the cortex below the electrode for a maximum of 30 minutes. Intervention 2: The second intervention group will be sham treatment during the first 15 sessions and after 5 days of rest, they will be treated with active TDCS method during 15 sessions. Active treatment of brain stimulation according to the tDCS protocol of cathedral type is done in daily sessions, each session for 30 minutes for fifteen days. Sham treatment is in such a way that the probes are placed on the head of the patients, but the electric current is not connected to it. Films and music are also used during the 30 minutes of tDCS and Sham treatment to help calm patients. After initial treatment, for 6 months, all three groups receive standard matrix psychotherapy and 6 sessions of relaxation training weekly. Intervention 3: The control group receives common treatment. In this way, for the treatment of opium (opium, etc.), The National Protocol f Agonist treatment will be used and for the treatment of methamphetamines, The Standard Matrix treatment will be used. 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 Sharing will take place after the end of the study
public Kiomars Najafi
Shafa educational center,15 Khordad St,Mosalla square,Rasht
Rasht Iran (Islamic Republic of) 4193955599 +98 13 3366 6268 k_najafi@gums.ac.ir Rasht University of Medical Sciences scientific Kiomars Najafi
Shafa educational center,15 Khordad St,Mosalla square,Rasht
Rasht Iran (Islamic Republic of) 4193955599 +98 13 3366 6268 k_najafi@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) patients with opioid or methamphetamine substance use disorders (based on DSM-5 criteria). 18 years 65 years Both Taking anticonvulsiant drugs in the last 6 months Having neurological diseases Pregnancy Mental retardation Presence of a complication in the skull Presence of any metal in the skull or brain F11.2 F15.2 Opioid dependence Other stimulant dependence Treatment - Other Treatment - Other Treatment - Other The first intervention group is treated daily with cathodic TDCS method in the first 15 sessions, and after 5 days of rest, they are treated with Sham in the next 15 sessions.Active treatment of brain stimulation according to the tDCS protocol of cathedral type is done in daily sessions, each session for 30 minutes for fifteen days. Each time a tDCS is performed (before and after each session), the patient is evaluated for any side effects.Sham treatment is in such a way that the probes are placed on the head of the patients, but the electric current is not connected to it. Films and music are also used during the 30 minutes of tDCS and Sham treatment to help calm patients. After initial treatment, for 6 months, all three groups receive standard matrix psychotherapy and 6 sessions of relaxation training weekly. In the present study, for brain stimulation, we used TDCS device that was devised by Paym-e Gilan Mehr (knowledge‑based company in Iran). The source of current is 18 V alkaline batteries with dimention about 32 cm × 21 cm × 11 cm; its weight is 5.1 kg In this study, 3 cathode leads and 3 anode leads are used. Each probe has two poles, positive and negative(3 cathode probes and 3 anode probes) has a cross-sectional area of 4 cm and a coating of rubber material is drawn on it, which easily transfers the current to the surface of the skull by the gel. The probes are placed side by side.Find that the cathodal leads are connected to each other without connecting to each other and in a triangular manner with the base downwards in the supraorbital regions of the right and fp2 in the EEG 10-20 system and the anodal leads in the left temporal-occipital region.(P1-C3- T7) is placed in the form of a triangle whose vertex is upwards and the base is outwards and downwards. The anode probes are placed slightly below the said level (limbic area of the brain).The electrodes are non-metallic and conductive and, after being impregnated with normal saline, are held in place by an elastic band in the scalp to facilitate transmission and reduce irritation in the skin area. After ensuring the placement of the electrodes, the tDCS device, which can be charged with an 18-volt battery, supplies direct and uniform direct current (up to 2 mA to each of the 3 electrodes) through the electrodes to the cortex below the electrode for a maximum of 30 minutes. The second intervention group will be sham treatment during the first 15 sessions and after 5 days of rest, they will be treated with active TDCS method during 15 sessions. Active treatment of brain stimulation according to the tDCS protocol of cathedral type is done in daily sessions, each session for 30 minutes for fifteen days. Sham treatment is in such a way that the probes are placed on the head of the patients, but the electric current is not connected to it. Films and music are also used during the 30 minutes of tDCS and Sham treatment to help calm patients. After initial treatment, for 6 months, all three groups receive standard matrix psychotherapy and 6 sessions of relaxation training weekly. The control group receives common treatment. In this way, for the treatment of opium (opium, etc.), The National Protocol f Agonist treatment will be used and for the treatment of methamphetamines, The Standard Matrix treatment will be used. The amount of craving. Timepoint: 6 months.During the follow-up period, patients will be evaluated for substance use in three stages of 1 month, 3 months and 6 months. Method of measurement: Addiction Craving Scale (ACS) questionnaire. Quality of life. Timepoint: Before the intervention and in the follow-up period of 1 month, 3 months and 6 months. Method of measurement: SF-36 questionnaire score. Data of EEG. Timepoint: Before the intervention and in the follow-up period of 1 month, 3 months and 6 months. Method of measurement: Brain signal processing. Guilan University of Medical Sciences Approved 2023-04-18 Research Ethics Committee of Guilan University of Medical Sciences University Research and Technology Vice-Chancellor,in front of 17 Shahrivar Hospital, Shahid Siyadati St, Namjo St, Rasht Rasht Guilan Iran (Islamic Republic of)