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IRCT20210214050363N1 IRCT 2021-06-14 Payam-e-Noor University The effect of tDCS on the treatment of neuropathic pain in diabetics Evaluation the effect of transcranial stimulation of the primary motor cortex (M1) in comparison with the transcranial stimulation of the primary motor cortex (M1) and the left dorsolateral prefrontal cortex (F3) on the bio-physiological and psychological status of patients with type 2 diabetes with neuropathic pain 2021-06-21 anticipated 30 Complete https://irct.ir/trial/54350 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In the present research, randomization will be block, and the randomization unit will be cluster. First, random assignment of patients (30 individuals) to 3 groups (first 10 patients for group A, then 10 patients for group B, and finally 10 patients for group C), is performed using the command to generate integer random numbers (INT = (RAND) * 30) the rand function of Excel software. After random assignment of patients to 3 groups, in the next step, random assignment of intervention type to three groups A, B, and C will be performed. Groups (intervention group 1; primary motor cortex stimulation (M1), intervention group 2; primary motor cortex stimulation (M1) and the left dorsolateral prefrontal cortex (F3), control group; placebo) will be written on three pieces of paper and will be folded, then, by randomly selecting the first paper from the three papers, the type of intervention of group A will be determined by selecting the second paper from the remaining two papers, the type of intervention of group B will be determined and the remaining third paper will determine the type of intervention for group C, Blinding description: This research is done double blindly. Because the device will be in the postdoctoral researcher's room (Roghayeh Mohammadi) and only she will be aware of the type of intervention for each person. In this study, in fact, diabetic patients in all three groups, clinical caregivers (nurse and the researcher's assistant psychologist who will be out of the room), and outcome assessors (both at the association and in the blood test laboratory), will not know the type of intervention assigned to each of the 3 groups. N/A Neuropathic pain in diabetes. Intervention 1: Intervention group 1: Primary motor cortical anodic tDCS group of the brain (M1); the group receives 12 sessions, 3 days a week; each session will last 40 minutes (20 minutes left M1 stimulation and 20 minutes right M1 stimulation) in that patients will receive transcranial direct current stimulation (tDCS) for the M1 region with 2 mA electrical current. Intervention 2: Intervention group 2: Primary motor cortical anodic tDCS group of the brain (M1) and the anodic tDCS of the left dorsolateral prefrontal cortex (F3); this group receives 12 sessions, 3 days a week. Therr will be 20 minutes of M1 anodic tDCS (10 minutes left M1 stimulation and 10 minutes of right M1 stimulation) and 20 minutes of F3 region anodic tDCS (left DLPFC) with 2 mA electrical current in each session. Intervention 3: Control group: placebo; for this group, the tDCS device, equipped with the default settings for sham stimulation, will provide real stimulation for 20 seconds, then despite remaining of the anode pad on M1 region for 20 minutes and F3 region for 20 minutes, the real stimulation will not happen for these regions. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identification of the individuals. When: En Access period starts 4 months after publishing the results. To whom: En Both for employed researchers in academic and scientific institutions and for people working in the industry. Conditions: En Any scientific and humanitarian use in order to help to relieve patients' neuropathic pain will be allowed. Where to obtain: Refer to Dr. Roghayeh Mohammadi by contact number: 00989141221070 and by email: rogayeh.mohammadi@gmail.com How to obtain: En In case of presenting introduction, reliable documents, and stating the purpose of obtaining the data, the requested data will be emailed to the applicant in a short time. Comments:
public Rogayeh mohammadi
Niayesh 7 Alley, Banafsheh Alley, Imam Street
Bonab Iran (Islamic Republic of) 5551744379 +98 41 3773 0075 rogayeh.mohammadi@gmail.com PayameNoor university scientific Rogayeh Mohammadi
Imam Street - Banafsheh Alley - Niayesh Alley 7
Bonab Iran (Islamic Republic of) 5551744379 +98 41 3773 0075 rogayeh.mohamadi@gmail.com PayameNoor university Iran (Islamic Republic of) Having at least 3 year history of diabetes Having neuropathic pain Not receiving psychological treatment since the diagnosis Having at least middle school education Being right-handed 30 years 55 years Both Acute psychological illness Having a pacemaker or intracardiac defibrillator G89.29 Other chronic pain Treatment - Devices Treatment - Devices Placebo Intervention group 1: Primary motor cortical anodic tDCS group of the brain (M1); the group receives 12 sessions, 3 days a week; each session will last 40 minutes (20 minutes left M1 stimulation and 20 minutes right M1 stimulation) in that patients will receive transcranial direct current stimulation (tDCS) for the M1 region with 2 mA electrical current. Intervention group 2: Primary motor cortical anodic tDCS group of the brain (M1) and the anodic tDCS of the left dorsolateral prefrontal cortex (F3); this group receives 12 sessions, 3 days a week. Therr will be 20 minutes of M1 anodic tDCS (10 minutes left M1 stimulation and 10 minutes of right M1 stimulation) and 20 minutes of F3 region anodic tDCS (left DLPFC) with 2 mA electrical current in each session. Control group: placebo; for this group, the tDCS device, equipped with the default settings for sham stimulation, will provide real stimulation for 20 seconds, then despite remaining of the anode pad on M1 region for 20 minutes and F3 region for 20 minutes, the real stimulation will not happen for these regions. Pain score on the McGill Pain Scale. Timepoint: Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention. Method of measurement: the McGill Pain Scale. HB A1c. Timepoint: Measurement of HB a1c before the study (last test in two-three months before the intervention), immediately after the last intervention session, 3 months after the intervention. Method of measurement: blood test. Glucagon. Timepoint: Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention. Method of measurement: blood test. Insulin. Timepoint: Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention. Method of measurement: blood test. Cortisol. Timepoint: Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention. Method of measurement: blood test. Metanephrine. Timepoint: Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention. Method of measurement: blood test. Normetanephrine. Timepoint: Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention. Method of measurement: blood test. White cell count. Timepoint: Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention. Method of measurement: blood test. Red blood cell count. Timepoint: Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention. Method of measurement: blood test. Platelets. Timepoint: Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention. Method of measurement: Platelets blood test. Depression. Timepoint: Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention. Method of measurement: The Depression Anxiety Stress Scale- DASS- 42. Anxiety. Timepoint: Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention. Method of measurement: The Depression Anxiety Stress Scale- DASS- 42. Sleep quality. Timepoint: Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention. Method of measurement: Pittsburgh Standard Sleep Quality Questionnaire. Quality of Life. Timepoint: Measurement of pain at the beginning of the study (before the intervention), immediately after the last intervention session, 30 days after the intervention. Method of measurement: Questionnaire 36 questions quality of life. Independently by researchers Approved 2020-12-12 Ethics committee of Payam-e-Noor University Graduate Studies Center of Payame Noor University, Safa Alley, Shahnaz Alley, Shahid Haj Mahmoud Nourian St., North Dibaji St., Farmanieh St. Tehran Tehran Iran (Islamic Republic of)