Effects of transcranial direct current stimulation on patients with disorders of consciousness after traumatic brain injury: study protocol for a randomized, double-blind controlled trial

Abstract

Background Disorders of consciousness (DOC) after traumatic brain injury (TBI) raise the mortality of patients, restrict the rehabilitation of patients with TBI, and increase the physical and economic burden that TBI imposes on patients and their families. Thus, treatment to promote early awakening in DOC after TBI is of vital importance. Various treatments have been reported, but there is no advanced evidence base to support them. Transcranial direct current stimulation (tDCS) has shown great potential in promoting neuroelectrochemical effects. This protocol is for a double-blind, randomized, controlled, clinical trial aiming to research the effects and safety of conventional rehabilitation combined with tDCS therapy in patients with DOC after TBI. Methods/design Eighty patients with DOC after TBI will be randomized into one of two groups receiving conventional rehabilitation combined with sham tDCS or conventional rehabilitation combined with active tDCS. The intervention period in each of the two groups will last 4 weeks (20 min per day, 6 days per week). Primary outcomes (Glasgow Outcome Scale (GOS)) will be measured at baseline and the end of every week from the first to the fourth week. Secondary outcomes will be measured at baseline and the end of the fourth week. Adverse events and untoward effects will be measured during each treatment. Discussion Patients with central nervous system lesions have received tDCS as a painless, non-invasive, easily applied and effective therapy for several decades, and there has been some evidence in recent years showing partial improvement on the level of consciousness of partial patients with DOC. However, reports mainly focus on the patients in a minimally conscious state (MCS), and there is a lack of large-sample clinical trials. This protocol presents an objective design for a randomized controlled trial that aims to study the effectiveness of conventional rehabilitation combined with tDCS therapy for DOC after TBI, to evaluate its safety, and to explore effective and economical therapeutic methods. Trial registration Chinese Clinical Trial Registry, ChiCTR1800014808. Registered on 7 February 2018.

Transcranial Direct Current Stimulation Over Prefrontal Areas Improves Psychomotor Inhibition State in Patients With Traumatic Brain Injury: A Pilot Study

“…Thibaut et al (2014) demonstrated that a single session of A-tDCS (2 mA/35 cm 2 × 20 min) over the left DLPFC in 55 patients with DoC (25 UWS and 30 MCS) might transiently improve the signs of consciousness in MCS following severe brain damage as measured by changes in CRS-R (1.6 ± 2.5) but no improvement in UWS. Angelakis et al (2014) using 10 sessions of A-tDCS (1 mA/25 cm 2 × 20 min) over the left DLPFC in four patients with DoC (three UWS and one MCS) could improve the MCS− patient to MCS+ immediately after the treatment; however, no patient in UWS improved immediately after stimulation. Interestingly, the MCS patient who received a second round of tDCS (2 mA/25 cm 2 × 20 min) at 3 months after the initial participation showed further improvement and emergence into consciousness after stimulation; but no change was detected in between the treatments.…”

Effect of Transcranial direct current stimulation (tDCS) on altered conscious patients after traumatic brain injury & cerebrovascular accident: A randomized clinical control trial

“…23 When a multi-area stimulation protocol is used, it will enhance the neurosynaptic pathways thus enabling the RAS to respond. The study by Li et al (2019) revealed that tDCS application increases the level of consciousness in the disorder of consciousness. 24 In our study we used the P3/ P4 electrode to stimulate the sensory cortex.…”

“…The study by Li et al (2019) revealed that tDCS application increases the level of consciousness in the disorder of consciousness. 24 In our study we used the P3/ P4 electrode to stimulate the sensory cortex. It is similar to multisensory stimulation which has proven results in attaining arousal response in altered conscious patients.…”

Development and Application of Medicine-Engineering Integration in the Rehabilitation of Traumatic Brain Injury

“…The emergence of posttraumatic disorders of consciousness (DOC) increases the mortality of patients and restricts their rehabilitation. A double-blind RCT study has found that tDCS can effectively improve the consciousness disorder of the people with TBI [ 40 ]. The systematic review of transcranial direct current stimulation (tDCS) effects on the rehabilitation of traumatic brain injury (TBI) also supported that although tDCS has been used in clinical treatment, it still needs further improvement, and the after-effects of tDCS are mostly short lived [ 41 ].…”