A long-term observational study on the efficacy and safety of implanted vagus nerve stimulation system for motor dysfunction in patients with ischemic stroke

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2600121604

Enrollment

Unknown

Registered

2026-04-01

Start date

2026-04-01

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

Motor dysfunction in patients with ischemic stroke

Interventions

Observation group:None

Eligibility

Sex/Gender

All

Age

22 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients with ischemic stroke who have already been implanted with a vagus nerve stimulation (VNS) system; any gender; aged >=22 and <=80 years. 2.Patients who are capable of communication, comprehension, providing informed consent, and complying with the study schedule. 3.Patients with good compliance, who are able to cooperate and complete 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.Participants who have had the VNS device removed or have discontinued its use. 2.Patients deemed unsuitable for participation by the investigator.

Design outcomes

Primary

Measure	Time frame
Fugl-Meyer(FMA-UE);	—

Secondary

Measure	Time frame
Change in Multishell Diffusion Tensor Imaging (DTI) metrics;Change in Resting-State functional MRI (rs-fMRI) metrics;Change in Resting-State Magnetoencephalography (MEG) metrics;Change in Fugl-Meyer Assessment of Lower Extremity (FMA-LE) score;Device Usability and Satisfaction;Change in Montreal Cognitive Assessment (MoCA) score;Change in Task-State Magnetoencephalography (MEG) metrics;Change in Wolf Motor Function Test (WMFT) score;Change in FMA Sensory Assessment Scale score;Change in Stroke Impact Scale (SIS) score;Change in EQ-5D-3L score;Change in Beck Depression Inventory (BDI) score;Change in Resting-State functional MRI (rs-fMRI) metrics;FMA-UE Response Rate;Change in walking speed of 10-Meter Walk Test (10MWT);Change in Modified Ashworth Scale (MAS) grade;WMFT Response Rate;Change in Modified Rankin Scale (mRS) grade;Patient Compliance;Incidence Rate of Adverse Events (AEs);	—

Measure

Time frame

Change in Multishell Diffusion Tensor Imaging (DTI) metrics;Change in Resting-State functional MRI (rs-fMRI) metrics;Change in Resting-State Magnetoencephalography (MEG) metrics;Change in Fugl-Meyer Assessment of Lower Extremity (FMA-LE) score;Device Usability and Satisfaction;Change in Montreal Cognitive Assessment (MoCA) score;Change in Task-State Magnetoencephalography (MEG) metrics;Change in Wolf Motor Function Test (WMFT) score;Change in FMA Sensory Assessment Scale score;Change in Stroke Impact Scale (SIS) score;Change in EQ-5D-3L score;Change in Beck Depression Inventory (BDI) score;Change in Resting-State functional MRI (rs-fMRI) metrics;FMA-UE Response Rate;Change in walking speed of 10-Meter Walk Test (10MWT);Change in Modified Ashworth Scale (MAS) grade;WMFT Response Rate;Change in Modified Rankin Scale (mRS) grade;Patient Compliance;Incidence Rate of Adverse Events (AEs);

—

Countries

China

Contacts

Public ContactLiang Chen

Huashan Hospital Affiliated to Fudan University

chenlianghs@126.com+86 21 65642662

Outcome results

None listed

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