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Long-term Efficacy and Safety of Implantable Vagus Nerve Stimulation System in Patients with Ischemic Stroke-related Motor Dysfunction: A Prospective Observational Study

Long-term Efficacy and Safety of Implantable Vagus Nerve Stimulation System in Patients with Ischemic Stroke-related Motor Dysfunction: A Prospective Observational Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600122085
Enrollment
Unknown
Registered
2026-04-08
Start date
2026-04-10
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Ischemic stroke is the most common type of stroke. It is an acute cerebrovascular disease caused by cerebral vascular occlusion, leading to ischemic and hypoxic necrosis of brain tissue and subsequent neurological deficits. Currently, it is generally classified into transient ischemic attack (TIA), reversible ischemic neurological deficit (RIND), progressive stroke, and complete stroke based on pa

Interventions

Patients with ischemic stroke who have been implanted with a vagus nerve stimulation (VNS) system:None

Sponsors

Zhujiang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1.Patients with ischemic stroke who have been implanted with a vagus nerve stimulation (VNS) system; 2.Patients with the ability to communicate, comprehend and provide informed consent, and who are able to adhere to the trial schedule; 3.Patients with good compliance who can cooperate to fulfill the follow-up requirements; 4.Completion of the Fugl-Meyer Assessment of Upper Extremity (FMA-UE) prior to VNS activation;

Exclusion criteria

Exclusion criteria: 1.Subjects who have had the VNS device removed or its use discontinued; 2.Subjects deemed inappropriate by the investigator;

Design outcomes

Primary

MeasureTime frame
Change in Fugl-Meyer Assessment of Upper Extremity Motor Function (FMA-UE) Score;

Secondary

MeasureTime frame
Change in Beck Depression Inventory (BDI) Score;FMA-UE Response Rate;Relevant Indicators of the Wolf Motor Function Test (WMFT);FMA-UE Response Rate;Change in Fugl-Meyer Assessment of Lower Extremity (FMA-LE) Score;

Countries

China

Contacts

Public ContactWu Wen

Zhujiang Hospital of Southern Medical University

910465988@qq.com+86 20 6278 3189

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026