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Study on the Neuromodulatory Mechanism of Closed-Loop Respiratory-Gated Vagus Nerve Stimulation in Reshaping Respiration-Swallowing Coordination to Improve Aspiration After Brainstem Stroke

Study on the Neuromodulatory Mechanism of Closed-Loop Respiratory-Gated Vagus Nerve Stimulation in Reshaping Respiration-Swallowing Coordination to Improve Aspiration After Brainstem Stroke

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125347
Enrollment
Unknown
Registered
2026-05-26
Start date
2026-05-29
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Stroke

Interventions

Intervention group:Respiratory-gated Auricular Vagal Afferent Nerve Stimulation, RAVANS
Aham stimulation group:RAVANS sham stimulation
Aspiration group after brainstem stroke:None
Non-aspiration group after brainstem stroke:None
Healthy Control Group:None

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients with brainstem stroke-induced aspiration: 1. Aged 25-80 years; 2. First-ever unilateral brainstem stroke, confirmed by cranial MRI or CT, with disease duration less than 1 year; 3. Impaired swallowing safety indicated by VFSS, with a PAS score > 5; 4. Ability to cooperate with relevant examinations, including fMRI and VFSS-synchronized respiratory-swallow coordination monitoring; 5. Ability to cooperate with follow-up visits; 6. Voluntary provision of written informed consent. Patients with brainstem stroke without aspiration: 1. Aged 25-80 years; 2. First-ever unilateral brainstem stroke, confirmed by cranial MRI or CT, with disease duration less than 1 year; 3. Intact or mildly impaired swallowing safety indicated by VFSS, with a PAS score <= 5; 4. Ability to cooperate with relevant examinations, including fMRI and VFSS-synchronized respiratory-swallow coordination monitoring; 5. Ability to cooperate with follow-up visits; 6. Voluntary provision of written informed consent. Healthy controls: 1. Aged 25-80 years; 2. Good general health status with independent living ability; 3. No swallowing dysfunction as screened by swallowing screening scales or the water swallow test; 4. Ability to follow instructions for examinations and voluntary provision of written informed consent.

Exclusion criteria

Exclusion criteria: 1. Presence of multiple neurological lesions involving the cerebral cortex or subcortex, brainstem, cranial nerves, etc.; 2. Use of prokinetic agents, H2 receptor antagonists, sedatives, analgesics, antidepressants, or anticholinergic drugs within one month prior to enrollment; history of laryngeal tumors or gastrointestinal motility disorders; presence of severe cardiopulmonary or renal complications; 3. Inability to undergo examinations due to implanted or retained metal objects, installation of electronic devices such as cardiac pacemakers, unstable medical conditions, etc.; 4. Severe claustrophobia or refusal to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Respiratory-swallow coordination;

Secondary

MeasureTime frame
Penetration-Aspiration Scale score;

Countries

China

Contacts

Public ContactQiao Jia

Third Affiliated Hospital of Sun Yat-sen University

xiaoqiao735922595@163.com+86 133 4021 2005

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026