This study aims to evaluate how transcranial focused ultrasound (tFUS) technology can promote neural network remodeling and functional recovery after stroke. By integrating signals from electroencephalography (EEG) and magnetic resonance imaging (MRI), the study will investigate how activating or inhibiting specific brain regions affects motor and cognitive recovery. The goal is to improve patients' motor and cognitive functions, reduce long-term disability, and enhance quality of life. The study also seeks to optimize stimulation parameters to maximize rehabilitation outcomes and explore the mechanisms underlying neuroprotection and functional reconstruction after stroke. This is a case-control study involving a total of 60 participants. Participants will be ischemic stroke survivors aged 18-75 years, with first-ever stroke onset between 21 days and 6 months, stable vital signs, no consciousness disorders, and the ability to provide informed consent and cooperate with assessments. Eligible participants must have unilateral limb motor impairment, with an upper extremity modified Ashworth score ≤3, Brunnstrom stage II-V, and an upper extremity Fugl-Meyer Assessment (FMA-UE) score between 15 and 60. Participants will be assigned to either a neuromodulation group (receiving multi-modal neuromodulation targeting specific brain regions) or a control group (receiving sham stimulation or conventional treatment). Primary outcome measures include changes in FMA-UE scores, neuroimaging data (CT/MRI), EEG measurements (resting-state and task-state spectral power, functional connectivity), and laboratory markers (complete blood count, CRP, IL-6, S100β, BDNF). Secondary outcome measures include Brunnstrom stage, Ashworth grade, muscle strength, and patient comfort ratings. Safety will be monitored through blood routine tests, blood biochemistry, and coagulation function. Statistical analysis will compare key indicator changes between the neuromodulation and control groups before and after intervention. Independent t-tests (for two groups) or ANOVA (for multiple groups) will be used to assess between-group differences, with non-parametric tests applied for data not following a normal distribution.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
60
The transcranial focused ultrasound stimulation device employed in this study is the NeuroFUS DPX-500, equipped with a 4-element transducer array and the BrainSight neuronavigation system. Individualized modeling and target segmentation are performed using high-resolution structural MRI and CT images acquired at baseline. Target planning and neuronavigation are conducted based on intracranial acoustic field simulation. The total stimulation duration is 12 minutes, comprising 480 pulse trains with 0.5 seconds on and 1 second off, yielding a duty cycle of 20%.
The control group receives sham stimulation during the neuromodulation phase. All procedural steps are identical to those of the experimental group, including neuronavigation positioning, application of coupling gel, and all other preparatory procedures; however, ultrasound stimulation is not activated. Participants in the control group wear bone-conduction headphones to simulate and counteract acoustic confounding. Group allocation information is blinded to participants.
Harbin Institute of Technology
Harbin, Heilongjiang, China
Upper extremity Fugl-Meyer Assessment (UE-FMA) motor score
Upper extremity motor function assessed by the Fugl-Meyer Assessment (motor subscale). Total score ranges from 0 to 66, with higher scores indicating better motor function.
Time frame: Baseline (Day 1), Day 7 ( after the 5-day intervention), and Day 21 (2-week follow-up)
Resting-state EEG spectral power
Resting-state EEG spectral power in the delta, theta, alpha, beta, and gamma frequency bands.
Time frame: Baseline (Day 1) and Day 7 (after the 5-day intervention)
Task-state EEG spectral power
Task-state EEG spectral power in the delta, theta, alpha, beta, and gamma frequency bands.
Time frame: Baseline (Day 1) and Day 7 (after the 5-day intervention)
Resting-state fMRI fractional ALFF (fALFF)
fALFF derived from resting-state functional MRI, the ratio of low-frequency power to whole-frequency power.
Time frame: Baseline (Day 1) and Day 7 (after the 5-day intervention)
Resting-state fMRI regional homogeneity (ReHo)
ReHo (Kendall's coefficient of concordance) from resting-state functional MRI, reflecting local synchronization of neuronal activity.
Time frame: Baseline (Day 1) and Day 7 (after the 5-day intervention)
Resting-state fMRI functional connectivity (FC)
Functional connectivity between regions of interest derived from resting-state functional MRI (Fisher z-transformed correlation coefficients).
Time frame: Baseline (Day 1) and Day 7 (after the 5-day intervention)
Brunnstrom recovery stage of the affected upper limb
Motor recovery staged using the Brunnstrom approach, an ordinal scale from Stage 1 (flaccid, no movement) to Stage 6 (near-normal coordination), with higher stages indicating better motor recovery.
Time frame: Baseline (Day 1), Day 7 (after the 5-day intervention), and Day 21 (2-week follow-up)
Modified Ashworth Scale (MAS) grade of the affected upper limb
Muscle spasticity graded with the Modified Ashworth Scale, an ordinal scale with 6 levels (0, 1, 1+, 2, 3, 4); higher grades indicate greater spasticity (a worse outcome).
Time frame: Baseline (Day 1), Day 7 (after the 5-day intervention), and Day 21 (2-week follow-up)
Fractional anisotropy (FA) on diffusion tensor imaging (DTI)
White-matter fractional anisotropy measured by diffusion tensor imaging. Dimensionless (0-1), with higher values indicating greater directional coherence of water diffusion.
Time frame: Baseline (Day 1) and Day 7 (after the 5-day intervention)
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