A prospective observational study on organ regulation by vagus nerve stimulation

A prospective observational study on organ regulation by vagus nerve stimulation - A prospective observational study on organ regulation by vagus nerve stimulation

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000045642

Enrollment

Registered

2021-10-02

Start date

2021-10-11

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Epilepsy

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with epilepsy that do not fully respond to anti-epileptic drugs and need a vagus nerve stimulator implantation.

Exclusion criteria

Exclusion criteria: (1) Patients who cannot measure scheduled test items. (2) Patients who are unable to visit the outpatient clinic for follow-up.

Design outcomes

Primary

Measure	Time frame
Changes in C-peptide levels before and 1 year after implantation of vagus nerve stimulator	—

Secondary

Measure	Time frame
Increase in C-peptide levels at 6 months and 2 years after vagus nerve stimulation, changes in glucose tolerance test, glucagon test, urinary C-peptide, continuous glucose, ECG R-R interval coefficient of variation, InBody, and blood samples at each evaluation time point.	—

Countries

Japan

Contacts

Public ContactSHINICHIRO OSAWA

Tohoku University Graduate School of Medicine Department of Neurosurgery

osawa@nsg.med.tohoku.ac.jp022-717-7230

Outcome results