title: Repetitive Transcranial Magnetic Stimulation (rTMS) for the cognitive rehabilitation of traumatic brain injury (TBI) victims: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Repetitive Transcranial Magnetic Stimulation (rTMS) has been proposed as a new tool in neurological rehabilitation of victims of traumatic brain injury (TBI). However, its usefulness to treat this condition has never been tested rigorously. The primary goal is to conduct a study protocol to determine whether rTMS used to cognitive rehabilitation of victims of TBI with diffuse axonal injury (DAI) is a safe instrument and if it enhances cognitive function recovery.
  
  
  METHODS
  Double-blind randomized controlled trial of patients with diffuse axonal injury. Thirty-six patients will be randomized to either an active coil group or sham group in a 1:1 ratio. rTMS protocol: 10 sessions of high-frequency rTMS (10 Hz) over the left dorsolateral prefrontal cortex (DLPFC). Cortical Excitability measures will be obtained. Neuropsychological evaluations will be performed 1 week before, 1 week and 3 months after rTMS. There are 2 study hypotheses: (1) rTMS over the left DLPFC in patients with DAI will improve cognitive function and (2) whether rTMS is safe in TBI patients.
  
  
  CONCLUSIONS
  This study evaluates the immediate and delayed effects of rTMS over the DLPFC on the cognitive domain of patients with DAI following TBI. rTMS has shown good results in treating major depression and may be promising for patients with TBI. As such, the results of this study can greatly modify the cognitive rehabilitation strategies.
  
  
  BACKGROUND
  This trial was registered in clinicaltrials.gov ( NCT02167971 ) on 17 June 2014.
authors.affiliation: Division of Neurosurgery, Hospital das Clínicas, University of São Paulo, Rua Dr Eneas Aguiar, 255 / 4079; 05403-010, São Paulo, SP, Brazil. iurineville@yahoo.com.br.|Service of Interdisciplinary Neuromodulation, University of São Paulo, São Paulo, Brazil. iurineville@yahoo.com.br.|Institute of Psychiatry, Hospital das Clínicas, University of São Paulo, São Paulo, Brazil. iurineville@yahoo.com.br.
authors.forename: Iuri Santana
authors.initials: IS
authors.lastname: Neville
authors.affiliation: Service of Interdisciplinary Neuromodulation, University of São Paulo, São Paulo, Brazil. cintya.hayashi@yahoo.com.br.|Nursing School, University of São Paulo, São Paulo, Brazil. cintya.hayashi@yahoo.com.br.
authors.forename: Cintya Yukie
authors.initials: CY
authors.lastname: Hayashi
authors.affiliation: Division of Neuropsychology, Hospital das Clínicas, University of São Paulo, São Paulo, Brazil. simoneaassis@gmail.com.
authors.forename: Simone Alves
authors.initials: SA
authors.lastname: El Hajj
authors.affiliation: Service of Interdisciplinary Neuromodulation, University of São Paulo, São Paulo, Brazil. ana.zaninotto@yahoo.com.br.|Division of Neuropsychology, Hospital das Clínicas, University of São Paulo, São Paulo, Brazil. ana.zaninotto@yahoo.com.br.
authors.forename: Ana Luiza Costa
authors.initials: AL
authors.lastname: Zaninotto
authors.affiliation: Division of Neuropsychology, Hospital das Clínicas, University of São Paulo, São Paulo, Brazil. jjjnperez@hotmail.com.
authors.forename: Juliana Perez
authors.initials: JP
authors.lastname: Sabino
authors.affiliation: Division of Neurosurgery, Hospital das Clínicas, University of São Paulo, Rua Dr Eneas Aguiar, 255 / 4079; 05403-010, São Paulo, SP, Brazil. leonardomoura.jr@hotmail.com.|Service of Interdisciplinary Neuromodulation, University of São Paulo, São Paulo, Brazil. leonardomoura.jr@hotmail.com.|Institute of Psychiatry, Hospital das Clínicas, University of São Paulo, São Paulo, Brazil. leonardomoura.jr@hotmail.com.
authors.forename: Leonardo Moura
authors.initials: LM
authors.lastname: Sousa
authors.affiliation: Service of Interdisciplinary Neuromodulation, University of São Paulo, São Paulo, Brazil. marcianagumo@gmail.com.
authors.forename: Marcia Mitie
authors.initials: MM
authors.lastname: Nagumo
authors.affiliation: Service of Interdisciplinary Neuromodulation, University of São Paulo, São Paulo, Brazil. brunowsky@gmail.com.|Institute of Psychiatry, Hospital das Clínicas, University of São Paulo, São Paulo, Brazil. brunowsky@gmail.com.
authors.forename: André Russowsky
authors.initials: AR
authors.lastname: Brunoni
authors.affiliation: Division of Neuropsychology, Hospital das Clínicas, University of São Paulo, São Paulo, Brazil. barbara@shieh.com.br.
authors.forename: Barbara Dal Forno Silva
authors.initials: BD
authors.lastname: Shieh
authors.affiliation: Division of Neurosurgery, Hospital das Clínicas, University of São Paulo, Rua Dr Eneas Aguiar, 255 / 4079; 05403-010, São Paulo, SP, Brazil. amorim.robson@gmail.com.|Service of Interdisciplinary Neuromodulation, University of São Paulo, São Paulo, Brazil. amorim.robson@gmail.com.|Institute of Psychiatry, Hospital das Clínicas, University of São Paulo, São Paulo, Brazil. amorim.robson@gmail.com.
authors.forename: Robson Luis Oliveira
authors.initials: RL
authors.lastname: Amorim
authors.affiliation: Division of Neurosurgery, Hospital das Clínicas, University of São Paulo, Rua Dr Eneas Aguiar, 255 / 4079; 05403-010, São Paulo, SP, Brazil. manoeljacobsen@gmail.com.|Service of Interdisciplinary Neuromodulation, University of São Paulo, São Paulo, Brazil. manoeljacobsen@gmail.com.|Institute of Psychiatry, Hospital das Clínicas, University of São Paulo, São Paulo, Brazil. manoeljacobsen@gmail.com.
authors.forename: Manoel Jacobsen
authors.initials: MJ
authors.lastname: Teixeira
authors.affiliation: Division of Neurosurgery, Hospital das Clínicas, University of São Paulo, Rua Dr Eneas Aguiar, 255 / 4079; 05403-010, São Paulo, SP, Brazil. wellingsonpaiva@yahoo.com.br.|Service of Interdisciplinary Neuromodulation, University of São Paulo, São Paulo, Brazil. wellingsonpaiva@yahoo.com.br.|Institute of Psychiatry, Hospital das Clínicas, University of São Paulo, São Paulo, Brazil. wellingsonpaiva@yahoo.com.br.
authors.forename: Wellingson Silva
authors.initials: WS
authors.lastname: Paiva
mesh_terms: D001938:Brazil; D002985:Clinical Protocols; D003071:Cognition; D020833:Diffuse Axonal Injury / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000534:rehabilitation*; D004311:Double-Blind Method; D006801:Humans; D009483:Neuropsychological Tests; D017397:Prefrontal Cortex / Q000503:physiopathology*; D011446:Prospective Studies; D020127:Recovery of Function; D012107:Research Design; D013997:Time Factors; D065908:Transcranial Direct Current Stimulation; D016896:Treatment Outcome