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Transcranial Focused Ultrasound Neuromodulation for Post-Stroke Motor Dysfunction

5 juni 2026 bijgewerkt door: Ming Chu, Jiangsu Taizhou People's Hospital

Transcranial Focused Ultrasound Neuromodulation in Post-Stroke Motor Dysfunction

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Harbin Institute of Technology
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Neuromodulation Group
Multimodal neuromodulation targeting specific neural regions in addition to conventional therapy.
Apparaat: 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 with 0.5 seconds on and 1 second off, yielding a duty cycle of 20%.
Sham-vergelijker: Control Group
Sham stimulation in addition to conventional therapy.
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Brunnstrom recovery stage of the affected upper limb
Tijdsspanne: 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.
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
Tijdsspanne: 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).
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)
Tijdsspanne: 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.
Baseline (Day 1) and Day 7 (after the 5-day intervention)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Jiangsu Taizhou People's Hospital

Medewerkers

Harbin Institute of Technology

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

31 december 2026

Studie voltooiing (Geschat)

31 maart 2028

Studieregistratiedata

Eerst ingediend

18 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 juni 2026

Eerst geplaatst (Werkelijk)

10 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

5 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • LSKY 2026-040-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be shared because the informed consent obtained from participants does not include provisions for sharing data outside the research team.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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