PMID- 29707203
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20191120
IS  - 2046-1402 (Print)
IS  - 2046-1402 (Electronic)
IS  - 2046-1402 (Linking)
VI  - 7
DP  - 2018
TI  - Repeated sessions of bilateral transcranial direct current stimulation on 
      intractable tinnitus: a study protocol for a double-blind randomized controlled 
      trial.
PG  - 317
LID - 10.12688/f1000research.13558.1 [doi]
LID - 317
AB  - Background: Transcranial Direct Current Stimulation (tDCS) is reportedly a 
      potential treatment option for chronic tinnitus. The main drawbacks of previous 
      studies are short term follow up and focusing on the efficacy of single session 
      tDCS. This study aims to investigate the therapeutic efficacy, adverse effects 
      (AEs) and tolerability of repeated sessions of bilateral tDCS over auditory 
      cortex (AC) on tinnitus symptoms Methods: This will be a double-blinded 
      randomized placebo controlled parallel trial on patients (n=90) with intractable 
      chronic tinnitus (> 2 years) randomly divided into three groups of anodal, 
      cathodal, and sham tDCS. In the sham treatment, after 30 sec the device will be 
      turned OFF without informing the patients. The tDCS protocol consists of 10 
      sessions (daily  20 min session; 2 mA current for 5 consecutive days per week and 
      2 consecutive weeks) applied through 35 cm (2) electrodes. The primary outcome is 
      tinnitus handicap inventory (THI) which will be assessed pre- and 
      post-intervention and at one month follow-up. The secondary outcomes are tinnitus 
      loudness and distress to be assessed using a visual analogue scale (VAS) 
      pre-intervention, and immediately, one hour, one week, and one month after last 
      stimulation. The AEs and tolerability of patients will be evaluated after each 
      session using a customized questionnaire. Possible interactions between the 
      disease features and treatment response will be evaluated.   Discussion: To our 
      knowledge this is the first study to investigate the effects of repeated sessions 
      of tDCS on chronic tinnitus symptoms with one month follow-up. In addition, the 
      AEs, and tolerability of patients will be studied. In addition, the possible 
      interactions between the disease specific features including the hearing loss, 
      laterality, type of tinnitus, and treatment response will be evaluated.   Trial 
      registration: The study has been registered as a clinical trial in Iranian 
      Registry of Clinical Trial ( IRCT2016110124635N6) on the 01/06/2017.
FAU - Bayat, Arash
AU  - Bayat A
AD  - Hearing Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, 
      61357-15794, Iran.
FAU - Mayo, Miguel
AU  - Mayo M
AUID- ORCID: 0000-0002-1829-6597
AD  - Department of Otorhinolaryngology, A Coruna University Hospital Complex, A 
      Coruna, 15006, Spain.
FAU - Rashidi, Samaneh
AU  - Rashidi S
AD  - Bioelectromagnetic Clinic, Imam Khomeini Hospital, Ahvaz Jundishapur University 
      of Medical Sciences, Ahvaz, 61936-73111, Iran.
FAU - Saki, Nader
AU  - Saki N
AD  - Hearing Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, 
      61357-15794, Iran.
FAU - Yadollahpour, Ali
AU  - Yadollahpour A
AUID- ORCID: 0000-0002-1216-2109
AD  - Bioelectromagnetic Clinic, Imam Khomeini Hospital, Ahvaz Jundishapur University 
      of Medical Sciences, Ahvaz, 61936-73111, Iran.
AD  - Department of Medical Physics, School of Medicine, Ahvaz Jundishapur University 
      of Medical Sciences, Ahvaz, 61357-33118, Iran.
LA  - eng
PT  - Journal Article
DEP - 20180314
PL  - England
TA  - F1000Res
JT  - F1000Research
JID - 101594320
PMC - PMC5887075
OTO - NOTNLM
OT  - Intractable chronic tinnitus
OT  - Repeated sessions
OT  - Tolerability
OT  - Transcranial direct current stimulation
OT  - adverse effects
OT  - bilateral
COIS- No competing interests were disclosed.
EDAT- 2018/05/01 06:00
MHDA- 2018/05/01 06:01
PMCR- 2018/03/14
CRDT- 2018/05/01 06:00
PHST- 2018/03/06 00:00 [accepted]
PHST- 2018/05/01 06:00 [entrez]
PHST- 2018/05/01 06:00 [pubmed]
PHST- 2018/05/01 06:01 [medline]
PHST- 2018/03/14 00:00 [pmc-release]
AID - 10.12688/f1000research.13558.1 [doi]
PST - epublish
SO  - F1000Res. 2018 Mar 14;7:317. doi: 10.12688/f1000research.13558.1. eCollection 
      2018.