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Spinal Cord Stimulation Combined With Motor Imagery Brain-Computer Interface for Chronic Post-Stroke Upper Limb Motor Dysfunction

30 giugno 2026 aggiornato da: Zhejiang Provincial People's Hospital

A Prospective, Single-Center, Non-Randomized, Parallel-Controlled Study to Evaluate the Efficacy and Safety of Spinal Cord Stimulation Combined With Non-Invasive Motor Imagery Brain-Computer Interface Rehabilitation Training for Upper Limb Motor Dysfunction in Patients With Chronic Stroke

This clinical study aims to evaluate the efficacy and safety of spinal cord stimulation combined with non-invasive motor imagery brain-computer interface rehabilitation training in patients with upper limb motor dysfunction after chronic stroke. The study includes an experimental group receiving spinal cord stimulation combined with motor imagery brain-computer interface rehabilitation training and a control group receiving motor imagery brain-computer interface rehabilitation training alone. The primary outcome is upper limb motor function assessed by the Fugl-Meyer Assessment for Upper Extremity. Secondary outcomes include muscle tone, upper limb functional activity, activities of daily living, adverse events, serious adverse events, and exploratory neurophysiological and neuroimaging indicators.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Upper limb motor dysfunction is a common and disabling sequela of stroke. Many patients enter a chronic phase more than 6 months after stroke onset, during which spontaneous recovery and conventional rehabilitation-related improvement often reach a plateau. Motor imagery brain-computer interface rehabilitation can decode motor intention from electroencephalographic signals and provide closed-loop feedback through external devices, thereby promoting cortical reorganization. However, in patients with impaired corticospinal pathways and insufficient residual motor execution capacity, the efficacy of motor imagery brain-computer interface training alone may be limited.

Spinal cord stimulation may facilitate spinal motor circuits, reduce abnormal muscle tone, and improve the excitability of residual descending motor pathways. Combining spinal cord stimulation with motor imagery brain-computer interface training may provide a synergistic central-peripheral neuromodulation strategy. The brain-computer interface decodes motor intention from the central nervous system, while spinal cord stimulation facilitates peripheral motor pathway execution, potentially enhancing motor recovery and neuroplasticity.

Participants will be assigned, according to patient preference and investigator assessment, to either the experimental group or the control group. The experimental group will undergo spinal cord stimulation implantation followed by individualized stimulation programming and standardized motor imagery brain-computer interface rehabilitation training. The control group will receive the same frequency and duration of motor imagery brain-computer interface rehabilitation training without spinal cord stimulation implantation. Clinical outcomes will be assessed at baseline, after 4 weeks of intervention, 2 months after intervention, and 3 months after intervention. Safety events will be recorded throughout the study. Exploratory assessments will include electroencephalography and neuroimaging to investigate potential mechanisms of neuroplasticity.

Tipo di studio

Interventistico

Iscrizione (Stimato)

66

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Zhejiang
      • Hangzhou, Zhejiang, Cina, 310014
        • Zhejiang Provincial People's Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Age 18 to 75 years.
  • First-ever unilateral supratentorial stroke, either ischemic or hemorrhagic, confirmed by computed tomography or magnetic resonance imaging, resulting in hemiparesis, with disease duration longer than 6 months.
  • At least one active movement in the wrist or fingers of the affected upper limb, with muscle strength of grade 1 or higher.
  • Fugl-Meyer Assessment for Upper Extremity score between 10 and 40, indicating moderate upper limb motor impairment.
  • Change in Fugl-Meyer Assessment score less than 10% within the previous month, indicating a functional plateau.
  • Clear consciousness and basically normal cognitive function, with Mini-Mental State Examination score of 24 or higher.
  • Stable clinical condition and ability to understand and cooperate with simple instructions and rehabilitation training.
  • Written informed consent voluntarily signed by the participant or legal guardian.

Exclusion Criteria:

  • Other neurological diseases that may cause motor dysfunction, such as Parkinson's disease, multiple sclerosis, or spinal cord injury.
  • Severe visual or auditory impairment that prevents cooperation with visual or auditory feedback instructions of the brain-computer interface system.
  • Contraindications to spinal cord stimulation surgery, such as severe coagulation dysfunction, infection at the puncture site, severe spinal deformity, or spinal canal stenosis.
  • History of epilepsy, intracranial metal implants, cardiac pacemaker, or other contraindications to magnetic resonance imaging.
  • Previous neuromodulation surgery for hemiparesis, such as spinal cord stimulation or deep brain stimulation.
  • Pregnancy or lactation.
  • Any other condition judged by the investigator to make the participant unsuitable for this study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Spinal Cord Stimulation Combined With Motor Imagery Brain-Computer Interface Training
Participants in this group will undergo spinal cord stimulation implantation followed by individualized stimulation programming. After stabilization of stimulation parameters, participants will receive standardized motor imagery brain-computer interface rehabilitation training for 4 weeks, 5 sessions per week.
Dispositivo: Spinal Cord Stimulation
Spinal cord stimulation will be delivered through epidural electrodes implanted at cervical spinal cord levels, typically C3-C7 for upper limb dysfunction. Stimulation parameters will be individually optimized within clinically safe and device-permitted ranges, including frequency, pulse width, amplitude, electrode configuration, and stimulation mode.
Dispositivo: Motor Imagery Brain-Computer Interface Rehabilitation Training
Motor imagery brain-computer interface training will use a 64-channel medical-grade electroencephalography cap to acquire scalp EEG signals. Participants will perform motor imagery tasks involving the affected upper limb, such as grasping, elbow extension, or wrist lifting. Sensorimotor rhythm features, especially mu rhythm and beta rhythm event-related desynchronization, will be extracted in real time. When significant event-related desynchronization is detected, the system will trigger external feedback, such as a soft robotic glove or functional electrical stimulation, to assist the affected limb in completing the target movement.
Comparatore attivo: Motor Imagery Brain-Computer Interface Rehabilitation Training
Participants in this group will receive the same frequency and duration of standardized motor imagery brain-computer interface rehabilitation training as the experimental group, for 4 weeks, 5 sessions per week. Training equipment, motor imagery tasks, and feedback methods will be consistent with those used in the experimental group.
Dispositivo: Motor Imagery Brain-Computer Interface Rehabilitation Training
Motor imagery brain-computer interface training will use a 64-channel medical-grade electroencephalography cap to acquire scalp EEG signals. Participants will perform motor imagery tasks involving the affected upper limb, such as grasping, elbow extension, or wrist lifting. Sensorimotor rhythm features, especially mu rhythm and beta rhythm event-related desynchronization, will be extracted in real time. When significant event-related desynchronization is detected, the system will trigger external feedback, such as a soft robotic glove or functional electrical stimulation, to assist the affected limb in completing the target movement.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Fugl-Meyer Assessment for Upper Extremity Score
Lasso di tempo: Baseline, Week 4, Week 8, and Week 12
The Fugl-Meyer Assessment for Upper Extremity will be used to evaluate motor function recovery of the affected upper limb.
Baseline, Week 4, Week 8, and Week 12

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Modified Ashworth Scale Score
Lasso di tempo: Baseline, Week 4, Week 8, and Week 12
The Modified Ashworth Scale will be used to assess muscle tone and spasticity of the affected upper limb.
Baseline, Week 4, Week 8, and Week 12
Change in Action Research Arm Test Score
Lasso di tempo: Baseline, Week 4, Week 8, and Week 12
The Action Research Arm Test will be used to assess functional activity of the affected upper limb, including grasp, grip, pinch, and gross movement.
Baseline, Week 4, Week 8, and Week 12
Change in Modified Barthel Index Score
Lasso di tempo: Baseline, Week 4, Week 8, and Week 12
The Modified Barthel Index will be used to assess activities of daily living.
Baseline, Week 4, Week 8, and Week 12
Incidence of Adverse Events and Serious Adverse Events
Lasso di tempo: From enrollment to Week 12
All adverse events and serious adverse events will be recorded and assessed throughout the study. Spinal cord stimulation-related adverse events may include intraoperative or postoperative bleeding, infection, cerebrospinal fluid leakage, electrode migration or fracture, implant rejection, postoperative pain, and neurological injury. Motor imagery brain-computer interface-related adverse events may include dizziness, visual fatigue, skin allergy related to electrode gel, training-related fatigue, and other discomfort.
From enrollment to Week 12

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Electroencephalographic Indicators
Lasso di tempo: Baseline, Week 4, and Week 12
Resting-state and motor imagery task-state 64-channel electroencephalography will be collected to analyze event-related desynchronization/synchronization, phase-lag-index-based functional connectivity, and graph-theoretical topological properties.
Baseline, Week 4, and Week 12
Change in Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging Indicators
Lasso di tempo: Baseline and Week 12
Resting-state functional magnetic resonance imaging and diffusion tensor imaging will be performed to assess changes in functional connectivity of the default mode network and sensorimotor network, as well as fractional anisotropy and mean diffusivity of major white matter tracts, including the corticospinal tract.
Baseline and Week 12

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Zhejiang Provincial People's Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 febbraio 2028

Completamento dello studio (Stimato)

1 maggio 2028

Date di iscrizione allo studio

Primo inviato

30 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 giugno 2026

Primo Inserito (Effettivo)

7 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KY2026089

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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