Ischemic Stroke
Conditions
Brief summary
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.
Interventions
DEVICETranscranial Focused Ultrasound Neuromodulation
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%.
DEVICESham Transcranial Focused Ultrasound Neuromodulation
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.
Sponsors
Jiangsu Taizhou People's Hospital
Harbin Institute of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* (1) Patients with a confirmed imaging diagnosis of first-ever ischemic stroke; (2) Unilateral limb motor involvement; (3) Modified Ashworth Scale (MAS) grade ≤3 for the upper extremity, Brunnstrom stage II-V, and upper extremity Fugl-Meyer Assessment (FMA-UE) score between 15 and 60 (inclusive); (4) Age 18-75 years, onset within 21 days to 6 months, in the subacute or recovery phase; (5) Stable vital signs, no consciousness impairment, informed consent provided, ability to cooperate with clinical assessments, and approval obtained from the institutional ethics committee.
Exclusion criteria
* (1) Contraindications to MRI; (2) Infarction involving the thalamus; (3) Risk of intracranial hemorrhage; (4) Presence of intracranial metallic foreign bodies, cardiac pacemakers, or cochlear implants; (5) Unstable medical condition, severe cognitive impairment or psychiatric disorders rendering the patient unable to comprehend the study or cooperate with assessments; (6) Conditions affecting limb motor function, including fractures, joint contractures, or severe limb spasticity; (7) Current use of medications that alter cortical excitability.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper extremity Fugl-Meyer Assessment (UE-FMA) motor score | Baseline (Day 1), Day 7 ( after the 5-day intervention), and Day 21 (2-week follow-up) | 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. |
| Resting-state EEG spectral power | Baseline (Day 1) and Day 7 (after the 5-day intervention) | Resting-state EEG spectral power in the delta, theta, alpha, beta, and gamma frequency bands. |
| Task-state EEG spectral power | Baseline (Day 1) and Day 7 (after the 5-day intervention) | Task-state EEG spectral power in the delta, theta, alpha, beta, and gamma frequency bands. |
| Resting-state fMRI fractional ALFF (fALFF) | Baseline (Day 1) and Day 7 (after the 5-day intervention) | fALFF derived from resting-state functional MRI, the ratio of low-frequency power to whole-frequency power. |
| Resting-state fMRI regional homogeneity (ReHo) | Baseline (Day 1) and Day 7 (after the 5-day intervention) | ReHo (Kendall's coefficient of concordance) from resting-state functional MRI, reflecting local synchronization of neuronal activity. |
| Resting-state fMRI functional connectivity (FC) | Baseline (Day 1) and Day 7 (after the 5-day intervention) | Functional connectivity between regions of interest derived from resting-state functional MRI (Fisher z-transformed correlation coefficients). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brunnstrom recovery stage of the affected upper limb | Baseline (Day 1), Day 7 (after the 5-day intervention), and Day 21 (2-week follow-up) | 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. |
| Modified Ashworth Scale (MAS) grade of the affected upper limb | Baseline (Day 1), Day 7 (after the 5-day intervention), and Day 21 (2-week follow-up) | 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). |
| Fractional anisotropy (FA) on diffusion tensor imaging (DTI) | Baseline (Day 1) and Day 7 (after the 5-day intervention) | White-matter fractional anisotropy measured by diffusion tensor imaging. Dimensionless (0-1), with higher values indicating greater directional coherence of water diffusion. |
Countries
China
Contacts
CONTACTXiao Zhang, Professor
Outcome results
None listed