Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Safety and Efficacy of Early Brain-Computer Interface Training After Reperfusion Therapy in Acute Ischemic Stroke (RT-BCI)

8 maja 2026 zaktualizowane przez: Shandong Provincial Hospital

This is a multicenter, prospective, randomized controlled trial designed to evaluate the efficacy, safety, and feasibility of early EEG-based non-invasive brain-computer interface (EEG-BCI) training as an add-on to standard early rehabilitation in patients with acute ischemic stroke (AIS) after reperfusion therapy. Eligible participants are adults aged 18 to 80 years with unilateral limb motor dysfunction after intravenous thrombolysis (IVT) and/or mechanical thrombectomy (MT). Participants will be randomized to receive either standard early rehabilitation plus closed-loop EEG-BCI dual-module virtual hand and gait training, or standard early rehabilitation alone.

The EEG-BCI intervention includes upper-limb virtual hand training and lower-limb gait/ankle dorsiflexion training, delivered twice daily for approximately 20 minutes per session over 5 consecutive days. The primary outcome is the change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score from baseline (T0) to Day 30. Secondary outcomes include upper- and lower-limb motor function, ambulation, neurological status, disability, and activities of daily living. Safety and feasibility outcomes will also be assessed.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

60

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • 1. Age 18 to 80 years.
  • 2. Acute ischemic stroke (AIS) treated with reperfusion therapy, including intravenous thrombolysis (IVT) and/or mechanical thrombectomy (MT); for participants undergoing MT, successful recanalization during the procedure defined as eTICI 2b-3.
  • 3. Meets the protocol-defined clinical stability criteria for the corresponding treatment pathway (see Section 4.3).
  • 4. Unilateral limb motor dysfunction on the same side as the dominant hand.
  • 5. Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score of 10 to 50 at T0.
  • 6. Pre-stroke modified Rankin Scale (mRS) score <= 2.
  • 7. Written informed consent provided by the participant and ability to comply with training and follow-up; if necessary, consent may be provided by a legally authorized representative.

Exclusion Criteria:

  • 1. Imaging-confirmed symptomatic intracranial hemorrhage (sICH), or bleeding risk considered unacceptable by the investigator and requiring a change in treatment strategy.
  • 2. Overt progressive neurological deterioration or need for urgent intervention, making training inappropriate, such as an increase in National Institutes of Health Stroke Scale (NIHSS) score of >=4 from a prior assessment with cause not yet clarified or stabilized.
  • 3. Severe disturbance of consciousness, severe aphasia or neglect, or significant cognitive impairment that would prevent completion of BCI training tasks or primary outcome assessment.
  • 4. Bilateral significant motor impairment, such as brainstem or bilateral lesions, or pre-existing moderate-to-severe disability of the contralateral upper or lower limb, which would interfere with training or interpretation of assessments under the unilateral impairment framework.
  • 5. Severe comorbidity or unstable vital signs, including but not limited to unstable arrhythmia, severe heart failure or respiratory failure, active severe infection or sepsis, or severe hepatic or renal failure, such that the investigator judges the participant unable to safely complete training and follow-up.
  • 6. Severe scalp skin damage or infection, or any other condition preventing safe use of the EEG electrode cap.
  • 7. Frequent seizures within 7 days before randomization, or seizure risk considered unacceptable by the investigator.
  • 8. Pregnancy or breastfeeding.
  • 9. Participation in another interventional clinical study that may affect the outcomes of this study, or any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Experimental BCI Rehabilitation Group
Standard early rehabilitation plus early EEG-BCI dual-module virtual hand and gait training
Urządzenie: EEG-based non-invasive brain-computer interface (BCI) virtual hand/gait training system
Closed-loop EEG-based non-invasive brain-computer interface training added to standard early rehabilitation, including virtual hand training for the upper limb and gait/ankle dorsiflexion training for the lower limb. Training is delivered twice daily, approximately 20 minutes per session, for 5 consecutive days.
Behawioralne: Standard Early Rehabilitation
Participants receive site-standard early rehabilitation according to the local rehabilitation protocol.
Aktywny komparator: Standard Early Rehabilitation Group
Standard early rehabilitation without additional BCI training.
Behawioralne: Standard Early Rehabilitation
Participants receive site-standard early rehabilitation according to the local rehabilitation protocol.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score
Ramy czasowe: Baseline (T0), Day 30
Change is calculated as the Day 30 FMA-UE score minus the baseline (T0) FMA-UE score. Higher positive values indicate greater improvement in upper-extremity motor function. T0 is defined as 48 hours after IVT for the IVT-only pathway, and Day 5 (120 ± 24 hours) after MT for the MT ± IVT pathway.
Baseline (T0), Day 30

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score
Ramy czasowe: Day 10 (±2 days), Day 30, Day 90
Upper-extremity motor impairment assessed using the Fugl-Meyer Assessment for Upper Extremity. Higher scores indicate better upper-extremity motor function.
Day 10 (±2 days), Day 30, Day 90
Action Research Arm Test (ARAT) score
Ramy czasowe: Day 10 (±2 days), Day 30, Day 90
Upper-limb activity limitation assessed using the Action Research Arm Test. Higher scores indicate better upper-limb function.
Day 10 (±2 days), Day 30, Day 90
Fugl-Meyer Assessment for Lower Extremity (FMA-LE) score
Ramy czasowe: Day 10 (±2 days), Day 30, Day 90
Lower-extremity motor impairment assessed using the Fugl-Meyer Assessment for Lower Extremity. Higher scores indicate better lower-extremity motor function.
Day 10 (±2 days), Day 30, Day 90
Functional Ambulation Category (FAC) score
Ramy czasowe: Day 10 (±2 days), Day 30, Day 90
Walking ability assessed using the Functional Ambulation Category. Higher scores indicate greater independence in ambulation.
Day 10 (±2 days), Day 30, Day 90
10-Meter Walk Test (10MWT) performance
Ramy czasowe: Day 10 (±2 days), Day 30, Day 90
Walking performance assessed by the 10-Meter Walk Test in participants who meet prespecified walking criteria. Walking speed and/or time required to complete the test will be recorded.
Day 10 (±2 days), Day 30, Day 90
Timed Up and Go (TUG) test performance
Ramy czasowe: Day 10 (±2 days), Day 30, Day 90
Functional mobility assessed by the Timed Up and Go test in participants who meet prespecified walking criteria. Time required to complete the test will be recorded.
Day 10 (±2 days), Day 30, Day 90
National Institutes of Health Stroke Scale (NIHSS) score
Ramy czasowe: Day 10 (±2 days), Day 30, Day 90
Neurological deficit severity assessed using the National Institutes of Health Stroke Scale. Lower scores indicate less severe neurological impairment.
Day 10 (±2 days), Day 30, Day 90
Modified Rankin Scale (mRS) score
Ramy czasowe: Day 30, Day 90
Global disability assessed using the modified Rankin Scale. Lower scores indicate less disability and greater functional independence.
Day 30, Day 90
Barthel Index (BI) / Modified Barthel Index (MBI) score
Ramy czasowe: Day 10 (±2 days), Day 30, Day 90
Activities of daily living assessed using the Barthel Index or Modified Barthel Index, according to the scale used at each study site. Higher scores indicate better functional independence in daily activities.
Day 10 (±2 days), Day 30, Day 90

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Screening-to-enrollment ratio
Ramy czasowe: Through completion of recruitment, an estimated 16 months
Feasibility outcome defined as the number of participants enrolled and randomized divided by the total number of participants screened.
Through completion of recruitment, an estimated 16 months
Intervention adherence rate
Ramy czasowe: During the 5-day intervention period
Feasibility outcome defined as the proportion of planned training sessions completed by each participant.
During the 5-day intervention period
Effective BCI training duration
Ramy czasowe: During the 5-day intervention period
Feasibility outcome defined as the cumulative duration of valid BCI training completed during the intervention period.
During the 5-day intervention period
EEG signal quality and classification accuracy
Ramy czasowe: During the 5-day intervention period
Feasibility outcome assessing the quality of EEG acquisition and the performance of signal classification during BCI training sessions.
During the 5-day intervention period
Follow-up completion rate
Ramy czasowe: Through Day 90
Feasibility outcome defined as the proportion of randomized participants who complete scheduled outcome assessments through Day 90.
Through Day 90
Protocol deviation rate
Ramy czasowe: From randomization through Day 90
Feasibility outcome defined as the proportion of participants with one or more protocol deviations.
From randomization through Day 90
Incidence of symptomatic intracranial hemorrhage
Ramy czasowe: From T0 through Day 30
Safety outcome defined as the occurrence of symptomatic intracranial hemorrhage after study enrollment.
From T0 through Day 30
Incidence of any intracranial hemorrhage
Ramy czasowe: From T0 through Day 30
Safety outcome defined as the occurrence of any type of intracranial hemorrhage after study enrollment.
From T0 through Day 30
Incidence of neurological deterioration
Ramy czasowe: From T0 through Day 30
Safety outcome defined as clinical neurological worsening after study enrollment according to the study protocol.
From T0 through Day 30
Incidence of seizures
Ramy czasowe: From T0 through Day 30
Safety outcome defined as the occurrence of seizure events after study enrollment.
From T0 through Day 30
Incidence of falls
Ramy czasowe: From T0 through Day 30
Safety outcome defined as the occurrence of falls during the study period.
From T0 through Day 30
Incidence of blood pressure or cardiac rhythm adverse events
Ramy czasowe: From T0 through Day 30
Safety outcome defined as blood pressure instability or cardiac arrhythmia events occurring during the study period.
From T0 through Day 30
Incidence of puncture-site bleeding or hematoma
Ramy czasowe: From T0 through Day 30
Safety outcome assessed in participants in the MT pathway, defined as puncture-site bleeding or hematoma after mechanical thrombectomy.
From T0 through Day 30
Incidence of training-related discomfort
Ramy czasowe: During the 5-day intervention period
Safety outcome defined as training-related discomfort, including fatigue, headache, skin irritation, or other reported discomfort associated with the intervention.
During the 5-day intervention period

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Shandong Provincial Hospital

Śledczy

  • Główny śledczy: QinJian Sun, MD, Shandong Provincial Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 kwietnia 2026

Zakończenie podstawowe (Szacowany)

1 kwietnia 2027

Ukończenie studiów (Szacowany)

1 czerwca 2027

Daty rejestracji na studia

Pierwszy przesłany

29 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 maja 2026

Pierwszy wysłany (Rzeczywisty)

13 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 maja 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • RT-BCI-2026-0219

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

The IPD will be available from Principal Investigators (Prof. Qinjian Sun) upon reasonable request 6 months after the trial completion.

Ramy czasowe udostępniania IPD

IPD will be made available 6 months after the completion of the trial.

Kryteria dostępu do udostępniania IPD

The IPD can be accessed by Principal Investigators (Prof. Qinjian Sun) 6 months after the completion of the trial, subject to a reasonable request.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF
  • ANALITYCZNY_KOD
  • CSR

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj