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.
Yeun Jie YooHye Jung ParkTae Yeong KimMi-Jeong YoonHyun Mi OhYoon Jung LeeBo Young HongDonghyeon KimTae-Woo KimSeong-Hoon LimPublished in: Brain sciences (2022)
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.
Keyphrases
- transcranial direct current stimulation
- upper limb
- randomized controlled trial
- working memory
- study protocol
- cerebral ischemia
- contrast enhanced
- magnetic resonance imaging
- atrial fibrillation
- resting state
- white matter
- diffusion weighted imaging
- functional connectivity
- systematic review
- clinical trial
- end stage renal disease
- machine learning
- subarachnoid hemorrhage
- newly diagnosed
- blood brain barrier
- virtual reality
- phase iii
- ejection fraction
- young adults
- high intensity
- peritoneal dialysis
- human health
- case control
- deep learning
- patient reported outcomes
- patient reported