Authors: Alexandra Santos; Iuri Neville, MD, PhD; Ana Zaninotto, PhD; Cintya Hayashi, MSc; Priscila Rodrigues; Ricardo Galhardoni; Daniel de Andrade, MD, PhD; André Brunoni, MD, PhD; Robson Amorim, MD, PhD; Manoel Teixeira, MD, PhD; Wellingson Paiva, MD, PhD (Sao Paulo, Brazil)

Introduction: To determine whether high frequency repetitive transcranial magnetic stimulation (rTMS) improves cognition in patients with severe traumatic brain injury. Methods: A single center, randomized, double-blind, placebo-controlled study of rTMS was conducted in patients aged 18 to 60 years with chronic (>12 months postinjury) diffuse axonal injury (DAI). Patients were randomized to either a  Sham  or  Real  group in a 1:1 ratio. A 10-session rTMS protocol was used with 10-Hz stimulation over the left dorsolateral prefrontal cortex (DLPFC). Neuropsychological assessments were performed at three time points, namely at baseline, after the 10 th  rTMS session, and 90 days after intervention. The primary outcome was change in executive function evaluated using the Trail Making Test Part B. Results: Thirty patients with chronic DAI met the study criteria. Between-group comparisons of performance on TMT Part B at baseline and after the 10 th  rTMS session did not differ between groups (P=0.680 and P=0.341, respectively). No significant differences were observed on other neuropsychological tests. There were no differences in adverse events between treatment groups was observed. Conclusion: Cognitive function in individuals with chronic DAI is not improved by high frequency rTMS over the left DLPFC, though it appears safe and well tolerated in this population. ClinicalTrials.gov identifier: NCT02167971