ABSTRACT
Introduction
Insomnia is a serious problem after traumatic brain injury (TBI) and partially improves via sleeping pills. We investigated the efficacy of transcranial direct current stimulation (tDCS) with a focus on the role of age and gender.
Materials and Methods
In a randomized double-blind clinical trial, 60 eligible TBI-induced insomnia patients were assigned to real and sham tDCS groups and were treated for three weeks. Sham but not real tDCS took sleeping pills for the first three weeks of the study and then used the placebo until the end of the study. The placebo was used by the real-tDCS group throughout the study. Sleep quality and insomnia severity were respectively evaluated by Pittsburg Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) at three time points.
Results
Real tDCS group reported lower mean ISI and PSQI scores at 3 weeks post treatment onset and maintained this decline for six weeks post treatment onset (P < 0.001). In younger participants and those identified as men, the treatment-induced attenuation of the mean PSQI score was reported higher and more lasting in real than sham tDCS groups.
Conclusion
Gender and age-specific tDCS protocols may be warranted to optimize the therapeutic effect of tDCS.
Acknowledgments
The authors would like to thank all the staff at Neuroscience Research Center, Guilan Road Trauma Research Centerat Guilan University of Medical Sciences, Rasht, who helped us in performing the data collection and study processes.
Disclosure statement
All authors declare that they have no conflict of interests.
Ethical approval
All applicable international, national, and/or institutional guidelines for study of human participants were performed by the authors. The study was approved by ethic committee of Guilan University of Medical Sciences (Ethic Code: IR.GUMS.REC.1398.182) that conforms to the provisions of the Declaration of Helsinki.
Consent to participate
All subjects participated in the current project after obtaining written consent.
Author Contributions
Author 1: Manuscript writing (supporting) & editing (equal); Author 2*: Conceptualization, Methodology,Writing manuscript draft, Funding acquisition, Supervision (Lead); Author 3: substantially revising&rewriting the manuscript; Author 4: Project administration (Lead), editing original draft (equal); Author 5: Sampling (Lead); Author 6: Investigation, Data collection(equal); Author 7: Investigation, Data collection(equal); Author 8: critically reviewing the article & reanalyzing and interpreting data, Author 9: Drafting figures and tables; Author 10: Data analysis (Lead)
Name and number of the trial register in www.irct.ir
The survey of transcranial direct current stimulation efficacy on the post-traumatic sleep quality, insomnia severity in the patients with mild traumatic brain injury during intermediate phase, IRCT20130416013027N2