Transcranial Focused Ultrasound Neuromodulation for Post-Stroke Motor Dysfunction
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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Xiao Zhang, Professor
- Número de teléfono: +86 18612228766
- Correo electrónico: zhangxiao@hit.edu.cn
Ubicaciones de estudio
-
-
Heilongjiang
-
Harbin, Heilongjiang, Porcelana, 150001
- Harbin Institute of Technology
-
Contacto:
- Xiao Zhang, Professor
- Número de teléfono: +86 18612228766
- Correo electrónico: zhangxiao@hit.edu.cn
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Neuromodulation Group
Multimodal neuromodulation targeting specific neural regions in addition to conventional therapy.
|
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%.
|
|
Comparador falso: Control Group
Sham stimulation in addition to conventional therapy.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Upper extremity Fugl-Meyer Assessment (UE-FMA) motor score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Brunnstrom recovery stage of the affected upper limb
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LSKY 2026-040-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .