Safety and therapeutic effects of personalized transcranial direct current stimulation based on electrical field simulation for prolonged disorders of consciousness: study protocol for a multi-center, double-blind, randomized controlled trial

Mi-Jeong Yoon; Hyun Mi Oh; TaeYeong Kim; Soo-Jin Choi; Woo Hee Choi; Hong Soo Jung; Sung Chul Lim; Yeun Jie Yoo; Hye Jung Park; Bo Young Hong; Geun-Young Park; Donghyeon Kim; Tae-Woo Kim; Sun Im; Seong Hoon Lim

doi:10.3389/fneur.2023.1184998

Safety and therapeutic effects of personalized transcranial direct current stimulation based on electrical field simulation for prolonged disorders of consciousness: study protocol for a multi-center, double-blind, randomized controlled trial

Front Neurol. 2023 Jun 29:14:1184998. doi: 10.3389/fneur.2023.1184998. eCollection 2023.

Authors

Mi-Jeong Yoon¹, Hyun Mi Oh², TaeYeong Kim³, Soo-Jin Choi⁴, Woo Hee Choi⁵, Hong Soo Jung⁶, Sung Chul Lim⁷, Yeun Jie Yoo¹, Hye Jung Park⁸, Bo Young Hong¹, Geun-Young Park⁴, Donghyeon Kim³, Tae-Woo Kim², Sun Im⁴, Seong Hoon Lim⁸

Affiliations

¹ Department of Rehabilitation Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
² Department of Rehabilitation Medicine, National Traffic Injury Rehabilitation Hospital, Gyeongki-do, Republic of Korea.
³ Research Institute, NEUROPHET Inc, Seoul, Republic of Korea.
⁴ Department of Rehabilitation Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
⁵ Division of Nuclear Medicine, Department of Radiology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
⁶ Department of Anesthesiology and Pain Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
⁷ Department of Neurology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
⁸ Department of Rehabilitation Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.

Abstract

Background: Disorders of consciousness (DOC) resulting from acquired brain injury (ABI) increase the mortality rate of patients, complicate rehabilitation, and increase the physical and economic burden that DOC imposes on patients and their families. Thus, treatment to promote early awakening from DOC is vital. Transcranial direct current stimulation (tDCS) has shown great potential for promoting neuro-electrochemical activity. However, previous tDCS studies did not consider structural damage or head and brain lesions, so the applicability of the results to all DOC patients was limited. In this study, to establish a patient-specific tDCS treatment plan considering the brain lesions of and damage sustained by DOC patients, we considered the electric field calculated by a the "finite electric" three-dimensional brain model based on magnetic resonance images. This protocol was developed to aid tDCS treatment of actual patients, and to verify its safety and effectiveness.

Methods/design: Twenty-four patients with DOC after ABI will be enrolled in this cross-over trial. All participants will receive typical rehabilitation combined with sham tDCS and typical rehabilitation plus personalized tDCS (P-tDCS). Each interventional period will last 2 weeks (30 min/day, 5 days/week). The primary outcome [score on the Korean version of the Coma Recovery Scale-Revised (K-CRS-R)] will be assessed at baseline and the end of the first day of the intervention. Secondary outcomes (K-CRS-R at 1 week and 2 weeks after experimental session and quantitative EEG changes quantitative electroencephalography changes) will be measured at baseline and the end of week 4. Adverse events will be recorded during each treatment session.

Discussion: For patients with neurological disorders, tDCS has served as a painless, non-invasive, easily applied, and effective therapy for several decades, and there is some evidence that it can improve the level of consciousness of patients with DOC. However, variability in the effects on consciousness among subjects have been reported and personalized strategies are lacking. This protocol is for a randomized controlled trial designed to validate the effectiveness and safety of P-tDCS combined with typical rehabilitation for DOC.

Clinical trial registration: https://cris.nih.go.kr, identifier KCT0007157.

Keywords: DOC; clinical trial; consciousness; minimal consciousness state; neuromodulation; non-invasive brain stimulation; transcranial direct current stimulation; vegetative state.