Effect of transcranial direct current stimulation on the level of consciousness in patients with traumatic coma: study protocol for a self-controlled trial

Background and objectives: Traumatic brain injury patients suffer from coma, which leads to changes in behavior and consciousness. There is a paucity of available treatments which can improve the level of consciousness. Transcranial direct current stimulation (tDCS) is one of the non-invasive techniques to stimulate the motor cortex and improve the level of consciousness. The purpose of the study will be to assess the effect of tDCS on consciousness in patients with traumatic coma. Subjects and methods: The single-subject ABA design single-center study will be conducted in the Neuro-Surgery ICU, Maharishi Markandeshwar Hospital, India. Comatose patients associate with traumatic brain injury will be recruited. After baseline assessment all patients will get treatment with tDCS for 20 minutes twice a day for consecutive 5 days. Follow-up assessment will be taken on every first day of the consecutive 1st, 3rd and 5th weeks post-treatment. Ethical approval has been obtained from the Institutional Ethical Committee (IEC) of Maharishi Markandeshwar (Deemed to be University) (IEC/MMDU/2018/1183) on June 6, 2018. Outcome measures: JFK Coma Recovery Scale-Revised (CRS-R). Discussion: The study will investigate the possible effect of tDCS in improving level of consciousness in patients with traumatic brain injury. Trial registration: The study was registered with ctri.nic.in (CTRI/2019/01/017186) on January 22, 2019. It is the official website for registration of clinical trials in India regulated by Indian Council of Medical Research.