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Multicenter, Randomized, Controlled Clinical Study of SSVEP-BCI Technology for the Treatment of Post-Stroke Dysphagia

Multicenter, Randomized, Controlled Clinical Study of SSVEP-BCI Technology for the Treatment of Post-Stroke Dysphagia / BCIIPSD-20260119

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125020
Enrollment
Unknown
Registered
2026-05-20
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-stroke dysphagia

Interventions

Control Group:Conventional neuromuscular electrical stimulation (NMES) for swallowing function combined with conventional swallowing rehabilitation therapy
Trial group:SSVEP-based brain-computer interface (BCI)-driven functional electrical stimulation for swallowing combined with conventional rehabilitation therapy

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18–80 years, regardless of gender; 2. First-ever hemorrhagic or ischemic stroke confirmed by imaging (computed tomography [CT] or magnetic resonance imaging [MRI]); 3. Within 6 months of symptom onset; 4. Presence of dysphagia, with Water Swallowing Test (WST) grade =3; 5. Mini-Mental State Examination (MMSE) score >24; 6. Absence of visual field defects and severe visual impairment; 7. Intact skull; 8. Clear consciousness, stable vital signs, and ability to understand and cooperate with research instructions; 9. Voluntary participation with signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Presence of severe cognitive impairment or aphasia, rendering the participant unable to understand and comply with research instructions; 2. Comorbid with other neurological disorders (e.g., Parkinson's disease, motor neuron disease) or head and neck tumors that cause dysphagia; 3. History of epilepsy; 4. Contraindications for electrical stimulation, such as cardiac pacemaker or intracranial metal implants; 5. Currently participating in other clinical trials that may influence the outcomes of this study.

Design outcomes

Primary

MeasureTime frame
Standard Swallowing Assessment;

Secondary

MeasureTime frame
Mini-Mental State Examination;Repetitive Saliva Swallowing Test;Functional Oral Intake Scale (FOIS);Swallowing-Related Quality of Life Scale;Penetration-Aspiration Scale;10-item Eating Assessment Tool;Water Swallowing Test;Dysphagia Outcome and Severity Scale (DOSS);

Countries

China

Contacts

Public ContactQiao Jin

The First Affiliated Hospital of Xi'an Jiaotong University

qiaojn123@163.com+86 29 85323215

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026