Rechargeable Implantable Vagus Nerve Stimulation System for Drug-Refractory Epilepsy

NCT05993117 | Unknown

• 1 other identifier: PINS-VNS-2101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the performance of automatic stimulation mode of a new rechargeable implantable vagus nerve stimulation system for drug-refractory epilepsy

Conditions

Drug-Refractory Epilepsy

Keywords

Vagus Nerve Stimulation

Outcome Measures

Primary Outcomes (2)

• Sensitivity of epilepsy detection

  Sensitivity is defined as the total number of seizures detected divided by the total number of seizures during the EMU stay.

  2-4 weeks after implant

• False positives for epilepsy detection

  A false positive event is defined when the IPG judged a seizure and triggered automatic mode stimulation ±2 minutes outside the time window of a actual seizure. The ratio of the total number of false positive events for all subjects to the monitoring time for all subjects during the EMU phase is defined as the false positive rate.

  2-4 weeks after implant

Secondary Outcomes (6)

• Changes in Seizure Frequency from Baseline

  up to 3 months Visit

• Change in seizure Severity

  up to 3 months Visit

• Change in Quality of Life

  up to 3 months Visit

• Heart rate recording accuracy

  1 to 2 weeks after implantation

• Duty cycle

  up to 3 months Visit

Study Arms (1)

G114R VNS system

EXPERIMENTAL

Device: G114R VNS system

Interventions

G114R VNS system DEVICE

All patients treated with Rechargeable Implantable Vagus Nerve Stimulation System (G114R)

G114R VNS system

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥3 years old; gender is not limited;
• Patients with clinically diagnosed drug-resistant epilepsy, suitable for vagus nerve stimulation therapy;
• At least 6 seizures per month;
• Patients with a history of increased heart rate (tachycardia) associated with seizure onset based on clinical data obtained from medical history, admission/hospital charts, or prior neurophysiologic evaluations;
• When the patient is lying on the left side and in an upright position, from the proposed electrode position on the neck to the proposed pulse generator on the chest, the peak-peak R-wave of the ECG should be higher than 0.40mV;
• Patients who are willing to undergo EMU phase assessment and activate the automatic mode function during this period;
• Patients must be in good general health and ambulatory;
• Children and guardians must be willing and able to give informed consent;
• Patients and their families have good compliance and can cooperate with the completion of postoperative follow-up requirements.

You may not qualify if:

• Patients have had a bilateral or left cervical vagotomy;
• One or both sides of the vagus nerve have lesions or damage;
• Patients have a history of VNS Therapy;
• Patients with a history of status epilepticus within 1 year prior to enrollment;
• Patients with a history of mental illness or pseudoepileptic seizures or epilepsy caused by intracranial space-occupying lesions;
• Patients currently use, or are expected to use, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy;
• Patients expected to require full body magnetic resonance imaging;
• VNS therapeutic system implants will bring unacceptable surgical or medical risks to patients (according to the judgment of the investigator);
• Patients with surgical contraindications identified by surgeons and anesthesiologists such as tumors, insulin-dependent diabetes mellitus or poor general condition;
• A record of clinically significant seizure-related bradycardia (heart rate below 50 bpm);
• Patients prescribed drugs specifically for a cardiac or autonomic disorder that in the investigator's opinion would affect heart rate response unless the patient has ictal tachycardia while taking said drugs. These include, but are not limited to, beta adrenergic antagonists ("beta blockers");
• Patients with known clinically significant arrhythmias, and patients with clinically significant arrhythmias identified by 24-hour ambulatory ECG recordings obtained at the screening visit;
• Adult patients with severe mental illness, severe cognitive impairment, history of severe depression, or suicidal tendencies, which, in the judgment of the investigator, would pose an unacceptable risk to the patient or prevent the patient from successfully completing the study;
• Abusing alcohol or use narcotic drugs;
• Women who are pregnant. Women of childbearing age must take a pregnancy test;

Sponsors & Collaborators

• Beijing Pins Medical Co., Ltd: lead
• Peking University First Hospital: collaborator
• Beijing Tiantan Hospital: collaborator

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ye Wu

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

• Jianguo Zhang

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianguang Sun

CONTACT

010-60736388; sunjianguang@pinsmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 15, 2023
• Study Start: September 1, 2021
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

CN (1)