Transcranial Focused Ultrasound Neuromodulation for Post-Stroke Motor Dysfunction

Official title

Transcranial Focused Ultrasound Neuromodulation in Post-Stroke Motor Dysfunction

Overview

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

• Device Transcranial 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 wit
• Device Sham 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.

Primary outcome measures

• Upper extremity Fugl-Meyer Assessment (UE-FMA) motor score [Time frame: Baseline (Day 1), Day 7 ( after the 5-day intervention), and Day 21 (2-week follow-up)]
• Resting-state EEG spectral power [Time frame: Baseline (Day 1) and Day 7 (after the 5-day intervention)]
• Task-state EEG spectral power [Time frame: Baseline (Day 1) and Day 7 (after the 5-day intervention)]
• Resting-state fMRI fractional ALFF (fALFF) [Time frame: Baseline (Day 1) and Day 7 (after the 5-day intervention)]
• Resting-state fMRI regional homogeneity (ReHo) [Time frame: Baseline (Day 1) and Day 7 (after the 5-day intervention)]
• Resting-state fMRI functional connectivity (FC) [Time frame: Baseline (Day 1) and Day 7 (after the 5-day intervention)]

Secondary outcome measures (3)

• Brunnstrom recovery stage of the affected upper limb [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 [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) [Time frame: Baseline (Day 1) and Day 7 (after the 5-day intervention)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Other

Study locations

China · 1 center

• Harbin Institute of Technology — Harbin

Identifiers

NCT: NCT07637825 · LSKY 2026-040-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗