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IRCT2016110124635N5 IRCT 2016-12-06 Ahvaz Jundishapur University of Medical ُSciences Transcranial direct current stimulation for chronic tinnitus treatment Clinical trial of comparison of effects of long term bifrontal anodal, cathodal, and sham treatment of transcranial direct current stimulation on tinnitus symptoms in patients with chronic idiopathic drug resistant tinnitus 2016-03-01 anticipated 75 Complete https://irct.ir/trial/20769 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A chronic tinnitus. Intervention 1: Anodal intervention group (n=25): Treatment protocol consists of daily one session (2 mA for 20 min with 35 cm2 electrode), 5 consecutive sessions per week for two consecutive weeks (10 sessions) where anode is placed at left dorsolateral prefrontal cortex (DLPFC) and cathode at right DLPFC. Intervention 2: Cathodal intervention group (n=25): Treatment protocol consists of daily one session (2 mA for 20 min with 35 cm2 electrode), 5 consecutive sessions per week for two consecutive weeks (10 sessions) where anode is placed at right dorsolateral prefrontal cortex (DLPFC) and cathode at left DLPFC. Intervention 3: Sham treatment (n=25): Treatment protocol is the same as anodal treatment, but after 40-50 sec the device will be turned OFF without informing the patients.
public Ali Yadollahpour
Bioelectromagnetic Clinic, Ahvaz Imam Khomeini Hospital, Azadegan St.
Ahvaz Iran (Islamic Republic of) 6135715794 +966 13 222 2925 yadollahpour.a@gmail.com Bioelectromagnetic Clinic, Ahvaz Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sci scientific Ali Yadollahpour
Bioelectromagnetic Clinic, Ahvaz Imam khomeini Hospital, Azadegan St.
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3222 2925 yadollahpour.a@gmail.com Bioelectromagnetic Clinic, Ahvaz Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sci Iran (Islamic Republic of) Inclusion criteria: chronic tinnitus for more than 6 months; resistance to medications; idiopathic tinnitus. Exclusion criteria: history of seizure attacks; high blood pressure; pace maker; brain trauma; severe psychiatric disorders. 18 years 70 years Both H93.1 chronic tinnitus Treatment - Devices Treatment - Devices Placebo Anodal intervention group (n=25): Treatment protocol consists of daily one session (2 mA for 20 min with 35 cm2 electrode), 5 consecutive sessions per week for two consecutive weeks (10 sessions) where anode is placed at left dorsolateral prefrontal cortex (DLPFC) and cathode at right DLPFC. Cathodal intervention group (n=25): Treatment protocol consists of daily one session (2 mA for 20 min with 35 cm2 electrode), 5 consecutive sessions per week for two consecutive weeks (10 sessions) where anode is placed at right dorsolateral prefrontal cortex (DLPFC) and cathode at left DLPFC. Sham treatment (n=25): Treatment protocol is the same as anodal treatment, but after 40-50 sec the device will be turned OFF without informing the patients. ُTinnitus Handicap Inventory (THI) Score. Timepoint: Pre intervention, Post intervention at one hour after last transcranial direct current stimulation (tDCS) session and at one month after last tDCS session. Method of measurement: THI questionnaire. Tinnitus intensity. Timepoint: Prior and post each transcranial direct current stimulation (tDCS) session (5 min after end of session), one week, and one month after last tDCS session. Method of measurement: Numerical rating scale (0 to 10). Tinnitus distress. Timepoint: Prior and post each transcranial direct current stimulation (tDCS) session (5 min after end of session), one week, and one month after last tDCS session. Method of measurement: Numerical rating scale (0 to 10). Ahvaz Jundishapur University of Medical ُSciences Approved 2016-02-13 Ethical research committee, Ahvaz Jundishapur University of Medical Sciences Deputy of Research, Ahvaz Jundishapur University of Medical Sciences, Golestan Blv.. Ahvaz Iran (Islamic Republic of)