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
BackgroundDisorders 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...
| Main Authors: | , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2023-06-01
|
| Series: | Frontiers in Neurology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fneur.2023.1184998/full |
| _version_ | 1797791801885589504 |
|---|---|
| author | 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 |
| author_facet | 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 |
| author_sort | Mi-Jeong Yoon |
| collection | DOAJ |
| description | BackgroundDisorders 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/designTwenty-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.DiscussionFor 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 registrationhttps://cris.nih.go.kr, identifier KCT0007157. |
| first_indexed | 2024-03-13T02:23:58Z |
| format | Article |
| id | doaj.art-4d89aef7a2d64fa5a55b765e7b63f9fc |
| institution | Directory Open Access Journal |
| issn | 1664-2295 |
| language | English |
| last_indexed | 2024-03-13T02:23:58Z |
| publishDate | 2023-06-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Neurology |
| spelling | doaj.art-4d89aef7a2d64fa5a55b765e7b63f9fc2023-06-30T05:42:08ZengFrontiers Media S.A.Frontiers in Neurology1664-22952023-06-011410.3389/fneur.2023.11849981184998Safety 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 trialMi-Jeong Yoon0Hyun Mi Oh1TaeYeong Kim2Soo-Jin Choi3Woo Hee Choi4Hong Soo Jung5Sung Chul Lim6Yeun Jie Yoo7Hye Jung Park8Bo Young Hong9Geun-Young Park10Donghyeon Kim11Tae-Woo Kim12Sun Im13Seong Hoon Lim14Department of Rehabilitation Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of KoreaDepartment of Rehabilitation Medicine, National Traffic Injury Rehabilitation Hospital, Gyeongki-do, Republic of KoreaResearch Institute, NEUROPHET Inc, Seoul, Republic of KoreaDepartment of Rehabilitation Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of KoreaDivision of Nuclear Medicine, Department of Radiology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of KoreaDepartment of Anesthesiology and Pain Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of KoreaDepartment of Neurology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of KoreaDepartment of Rehabilitation Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of KoreaDepartment of Rehabilitation Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of KoreaDepartment of Rehabilitation Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of KoreaDepartment of Rehabilitation Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of KoreaResearch Institute, NEUROPHET Inc, Seoul, Republic of KoreaDepartment of Rehabilitation Medicine, National Traffic Injury Rehabilitation Hospital, Gyeongki-do, Republic of KoreaDepartment of Rehabilitation Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of KoreaDepartment of Rehabilitation Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of KoreaBackgroundDisorders 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/designTwenty-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.DiscussionFor 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 registrationhttps://cris.nih.go.kr, identifier KCT0007157.https://www.frontiersin.org/articles/10.3389/fneur.2023.1184998/fullnon-invasive brain stimulationDOCconsciousnesstranscranial direct current stimulationneuromodulationclinical trial |
| spellingShingle | 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 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 Frontiers in Neurology non-invasive brain stimulation DOC consciousness transcranial direct current stimulation neuromodulation clinical trial |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | non-invasive brain stimulation DOC consciousness transcranial direct current stimulation neuromodulation clinical trial |
| url | https://www.frontiersin.org/articles/10.3389/fneur.2023.1184998/full |
| work_keys_str_mv | AT mijeongyoon safetyandtherapeuticeffectsofpersonalizedtranscranialdirectcurrentstimulationbasedonelectricalfieldsimulationforprolongeddisordersofconsciousnessstudyprotocolforamulticenterdoubleblindrandomizedcontrolledtrial AT hyunmioh safetyandtherapeuticeffectsofpersonalizedtranscranialdirectcurrentstimulationbasedonelectricalfieldsimulationforprolongeddisordersofconsciousnessstudyprotocolforamulticenterdoubleblindrandomizedcontrolledtrial AT taeyeongkim safetyandtherapeuticeffectsofpersonalizedtranscranialdirectcurrentstimulationbasedonelectricalfieldsimulationforprolongeddisordersofconsciousnessstudyprotocolforamulticenterdoubleblindrandomizedcontrolledtrial AT soojinchoi safetyandtherapeuticeffectsofpersonalizedtranscranialdirectcurrentstimulationbasedonelectricalfieldsimulationforprolongeddisordersofconsciousnessstudyprotocolforamulticenterdoubleblindrandomizedcontrolledtrial AT wooheechoi safetyandtherapeuticeffectsofpersonalizedtranscranialdirectcurrentstimulationbasedonelectricalfieldsimulationforprolongeddisordersofconsciousnessstudyprotocolforamulticenterdoubleblindrandomizedcontrolledtrial AT hongsoojung safetyandtherapeuticeffectsofpersonalizedtranscranialdirectcurrentstimulationbasedonelectricalfieldsimulationforprolongeddisordersofconsciousnessstudyprotocolforamulticenterdoubleblindrandomizedcontrolledtrial AT sungchullim safetyandtherapeuticeffectsofpersonalizedtranscranialdirectcurrentstimulationbasedonelectricalfieldsimulationforprolongeddisordersofconsciousnessstudyprotocolforamulticenterdoubleblindrandomizedcontrolledtrial AT yeunjieyoo safetyandtherapeuticeffectsofpersonalizedtranscranialdirectcurrentstimulationbasedonelectricalfieldsimulationforprolongeddisordersofconsciousnessstudyprotocolforamulticenterdoubleblindrandomizedcontrolledtrial AT hyejungpark safetyandtherapeuticeffectsofpersonalizedtranscranialdirectcurrentstimulationbasedonelectricalfieldsimulationforprolongeddisordersofconsciousnessstudyprotocolforamulticenterdoubleblindrandomizedcontrolledtrial AT boyounghong safetyandtherapeuticeffectsofpersonalizedtranscranialdirectcurrentstimulationbasedonelectricalfieldsimulationforprolongeddisordersofconsciousnessstudyprotocolforamulticenterdoubleblindrandomizedcontrolledtrial AT geunyoungpark safetyandtherapeuticeffectsofpersonalizedtranscranialdirectcurrentstimulationbasedonelectricalfieldsimulationforprolongeddisordersofconsciousnessstudyprotocolforamulticenterdoubleblindrandomizedcontrolledtrial AT donghyeonkim safetyandtherapeuticeffectsofpersonalizedtranscranialdirectcurrentstimulationbasedonelectricalfieldsimulationforprolongeddisordersofconsciousnessstudyprotocolforamulticenterdoubleblindrandomizedcontrolledtrial AT taewookim safetyandtherapeuticeffectsofpersonalizedtranscranialdirectcurrentstimulationbasedonelectricalfieldsimulationforprolongeddisordersofconsciousnessstudyprotocolforamulticenterdoubleblindrandomizedcontrolledtrial AT sunim safetyandtherapeuticeffectsofpersonalizedtranscranialdirectcurrentstimulationbasedonelectricalfieldsimulationforprolongeddisordersofconsciousnessstudyprotocolforamulticenterdoubleblindrandomizedcontrolledtrial AT seonghoonlim safetyandtherapeuticeffectsofpersonalizedtranscranialdirectcurrentstimulationbasedonelectricalfieldsimulationforprolongeddisordersofconsciousnessstudyprotocolforamulticenterdoubleblindrandomizedcontrolledtrial |