MRI-Based Personalized Transcranial Direct Current Stimulation to Enhance the Upper Limb Function in Patients with Stroke: Study Protocol for a Double-Blind Randomized Controlled Trial
Transcranial direct current stimulation (tDCS) has been shown to have the potential to improve the motor recovery of the affected upper limbs in patients with stroke, and recently, several optimized tDCS methods have been proposed to magnify its effectiveness. This study aims to determine the effect...
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2022-12-01
|
| Series: | Brain Sciences |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2076-3425/12/12/1673 |
| _version_ | 1797461126985809920 |
|---|---|
| author | Yeun Jie Yoo Hye Jung Park Tae Yeong Kim Mi-Jeong Yoon Hyun-Mi Oh Yoon Jung Lee Bo Young Hong Donghyeon Kim Tae-Woo Kim Seong Hoon Lim |
| author_facet | Yeun Jie Yoo Hye Jung Park Tae Yeong Kim Mi-Jeong Yoon Hyun-Mi Oh Yoon Jung Lee Bo Young Hong Donghyeon Kim Tae-Woo Kim Seong Hoon Lim |
| author_sort | Yeun Jie Yoo |
| collection | DOAJ |
| description | Transcranial direct current stimulation (tDCS) has been shown to have the potential to improve the motor recovery of the affected upper limbs in patients with stroke, and recently, several optimized tDCS methods have been proposed to magnify its effectiveness. This study aims to determine the effectiveness of personalized tDCS using brain MRI-based electrical field simulation and optimization, to enhance motor recovery of the upper limbs in the patients. This trial is a double-blind, randomized controlled trial in the subacute to chronic rehabilitation phase. Forty-two adult stroke patients with unilateral upper limb involvement will be randomly allocated to three groups: (1) personalized tDCS with MRI-based electrical field simulation and optimized stimulation, (2) conventional tDCS with bihemispheric stimulation of the primary motor cortex, and (3) sham tDCS. All three groups will undergo 10 intervention sessions with 30 min of 2-mA intensity stimulation, during a regular upper limb rehabilitation program over two weeks. The primary outcome measure for the motor recovery of the upper limb impairment is the Fugl–Meyer assessment for the upper extremity score at the end of the intervention, and the secondary measures include changes in the motor evoked potentials, the frequency power and coherence of the electroencephalography, performance in activities of daily living, and adverse events with a 1-month follow-up assessment. The primary outcome will be analyzed on the intention-to-treat principle. There is a paucity of studies regarding the effectiveness of personalized and optimized tDCS that considers individual brain lesions and electrical field characteristics in the real world. No feasibility or pivotal studies have been performed in stroke patients using brain MRI, to determine a lesion-specific tDCS simulation and optimization that considers obstacles in the segmentation and analysis of the affected brain tissue, such as ischemic and hemorrhagic lesions. This trial will contribute to addressing the effectiveness and safety of personalized tDCS, using brain MRI-based electrical field simulation and optimization, to enhance the motor recovery of the upper limbs in patients with stroke. |
| first_indexed | 2024-03-09T17:14:59Z |
| format | Article |
| id | doaj.art-1850bea35e92496b97dbd4481f874680 |
| institution | Directory Open Access Journal |
| issn | 2076-3425 |
| language | English |
| last_indexed | 2024-03-09T17:14:59Z |
| publishDate | 2022-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Brain Sciences |
| spelling | doaj.art-1850bea35e92496b97dbd4481f8746802023-11-24T13:39:45ZengMDPI AGBrain Sciences2076-34252022-12-011212167310.3390/brainsci12121673MRI-Based Personalized Transcranial Direct Current Stimulation to Enhance the Upper Limb Function in Patients with Stroke: Study Protocol for a Double-Blind Randomized Controlled TrialYeun Jie Yoo0Hye Jung Park1Tae Yeong Kim2Mi-Jeong Yoon3Hyun-Mi Oh4Yoon Jung Lee5Bo Young Hong6Donghyeon Kim7Tae-Woo Kim8Seong Hoon Lim9Department of Rehabilitation Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Seoul 16247, Republic of KoreaDepartment of Rehabilitation Medicine, National Traffic Injury Rehabilitation Hospital, Yangpyeong 12564, Republic of KoreaResearch Institute, NEUROPHET Inc., Seoul 06234, Republic of KoreaDepartment of Rehabilitation Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Seoul 16247, Republic of KoreaDepartment of Rehabilitation Medicine, National Traffic Injury Rehabilitation Hospital, Yangpyeong 12564, Republic of KoreaDepartment of Rehabilitation Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Seoul 16247, Republic of KoreaDepartment of Rehabilitation Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Seoul 16247, Republic of KoreaResearch Institute, NEUROPHET Inc., Seoul 06234, Republic of KoreaDepartment of Rehabilitation Medicine, National Traffic Injury Rehabilitation Hospital, Yangpyeong 12564, Republic of KoreaDepartment of Rehabilitation Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Seoul 16247, Republic of KoreaTranscranial direct current stimulation (tDCS) has been shown to have the potential to improve the motor recovery of the affected upper limbs in patients with stroke, and recently, several optimized tDCS methods have been proposed to magnify its effectiveness. This study aims to determine the effectiveness of personalized tDCS using brain MRI-based electrical field simulation and optimization, to enhance motor recovery of the upper limbs in the patients. This trial is a double-blind, randomized controlled trial in the subacute to chronic rehabilitation phase. Forty-two adult stroke patients with unilateral upper limb involvement will be randomly allocated to three groups: (1) personalized tDCS with MRI-based electrical field simulation and optimized stimulation, (2) conventional tDCS with bihemispheric stimulation of the primary motor cortex, and (3) sham tDCS. All three groups will undergo 10 intervention sessions with 30 min of 2-mA intensity stimulation, during a regular upper limb rehabilitation program over two weeks. The primary outcome measure for the motor recovery of the upper limb impairment is the Fugl–Meyer assessment for the upper extremity score at the end of the intervention, and the secondary measures include changes in the motor evoked potentials, the frequency power and coherence of the electroencephalography, performance in activities of daily living, and adverse events with a 1-month follow-up assessment. The primary outcome will be analyzed on the intention-to-treat principle. There is a paucity of studies regarding the effectiveness of personalized and optimized tDCS that considers individual brain lesions and electrical field characteristics in the real world. No feasibility or pivotal studies have been performed in stroke patients using brain MRI, to determine a lesion-specific tDCS simulation and optimization that considers obstacles in the segmentation and analysis of the affected brain tissue, such as ischemic and hemorrhagic lesions. This trial will contribute to addressing the effectiveness and safety of personalized tDCS, using brain MRI-based electrical field simulation and optimization, to enhance the motor recovery of the upper limbs in patients with stroke.https://www.mdpi.com/2076-3425/12/12/1673transcranial electrical stimulationtranscranial direct current stimulationnon-invasive brain stimulationstrokeupper limbneuromodulation |
| spellingShingle | Yeun Jie Yoo Hye Jung Park Tae Yeong Kim Mi-Jeong Yoon Hyun-Mi Oh Yoon Jung Lee Bo Young Hong Donghyeon Kim Tae-Woo Kim Seong Hoon Lim MRI-Based Personalized Transcranial Direct Current Stimulation to Enhance the Upper Limb Function in Patients with Stroke: Study Protocol for a Double-Blind Randomized Controlled Trial Brain Sciences transcranial electrical stimulation transcranial direct current stimulation non-invasive brain stimulation stroke upper limb neuromodulation |
| title | MRI-Based Personalized Transcranial Direct Current Stimulation to Enhance the Upper Limb Function in Patients with Stroke: Study Protocol for a Double-Blind Randomized Controlled Trial |
| title_full | MRI-Based Personalized Transcranial Direct Current Stimulation to Enhance the Upper Limb Function in Patients with Stroke: Study Protocol for a Double-Blind Randomized Controlled Trial |
| title_fullStr | MRI-Based Personalized Transcranial Direct Current Stimulation to Enhance the Upper Limb Function in Patients with Stroke: Study Protocol for a Double-Blind Randomized Controlled Trial |
| title_full_unstemmed | MRI-Based Personalized Transcranial Direct Current Stimulation to Enhance the Upper Limb Function in Patients with Stroke: Study Protocol for a Double-Blind Randomized Controlled Trial |
| title_short | MRI-Based Personalized Transcranial Direct Current Stimulation to Enhance the Upper Limb Function in Patients with Stroke: Study Protocol for a Double-Blind Randomized Controlled Trial |
| title_sort | mri based personalized transcranial direct current stimulation to enhance the upper limb function in patients with stroke study protocol for a double blind randomized controlled trial |
| topic | transcranial electrical stimulation transcranial direct current stimulation non-invasive brain stimulation stroke upper limb neuromodulation |
| url | https://www.mdpi.com/2076-3425/12/12/1673 |
| work_keys_str_mv | AT yeunjieyoo mribasedpersonalizedtranscranialdirectcurrentstimulationtoenhancetheupperlimbfunctioninpatientswithstrokestudyprotocolforadoubleblindrandomizedcontrolledtrial AT hyejungpark mribasedpersonalizedtranscranialdirectcurrentstimulationtoenhancetheupperlimbfunctioninpatientswithstrokestudyprotocolforadoubleblindrandomizedcontrolledtrial AT taeyeongkim mribasedpersonalizedtranscranialdirectcurrentstimulationtoenhancetheupperlimbfunctioninpatientswithstrokestudyprotocolforadoubleblindrandomizedcontrolledtrial AT mijeongyoon mribasedpersonalizedtranscranialdirectcurrentstimulationtoenhancetheupperlimbfunctioninpatientswithstrokestudyprotocolforadoubleblindrandomizedcontrolledtrial AT hyunmioh mribasedpersonalizedtranscranialdirectcurrentstimulationtoenhancetheupperlimbfunctioninpatientswithstrokestudyprotocolforadoubleblindrandomizedcontrolledtrial AT yoonjunglee mribasedpersonalizedtranscranialdirectcurrentstimulationtoenhancetheupperlimbfunctioninpatientswithstrokestudyprotocolforadoubleblindrandomizedcontrolledtrial AT boyounghong mribasedpersonalizedtranscranialdirectcurrentstimulationtoenhancetheupperlimbfunctioninpatientswithstrokestudyprotocolforadoubleblindrandomizedcontrolledtrial AT donghyeonkim mribasedpersonalizedtranscranialdirectcurrentstimulationtoenhancetheupperlimbfunctioninpatientswithstrokestudyprotocolforadoubleblindrandomizedcontrolledtrial AT taewookim mribasedpersonalizedtranscranialdirectcurrentstimulationtoenhancetheupperlimbfunctioninpatientswithstrokestudyprotocolforadoubleblindrandomizedcontrolledtrial AT seonghoonlim mribasedpersonalizedtranscranialdirectcurrentstimulationtoenhancetheupperlimbfunctioninpatientswithstrokestudyprotocolforadoubleblindrandomizedcontrolledtrial |