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Rechargeable Implantable Vagus Nerve Stimulation System for Drug-Refractory Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05993117
Recruitment Status : Recruiting
First Posted : August 15, 2023
Last Update Posted : September 13, 2023
Sponsor:
Collaborators:
Peking University First Hospital
Beijing Tiantan Hospital
Information provided by (Responsible Party):
Beijing Pins Medical Co., Ltd

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

Condition or disease Intervention/treatment Phase
Drug-Refractory Epilepsy Device: G114R VNS system Not Applicable

Detailed Description:
The study is a prospective, single-group, open-lable trial designed to collect data on patients implanted with a Model G114R VNS system (Beijing PINS Medical) from baseline through an EMU (epilepsy monitoring unit) stay of up to 5 days, and 3-mouth follow-up. The seizure burden and quality of life were evaluated. Adverse events were recorded during the trial.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rechargeable Implantable Vagus Nerve Stimulation System for Drug-Refractory Epilepsy
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Medicines

Arms and Interventions
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Arm Intervention/treatment
Experimental: G114R VNS system Device: G114R VNS system
All patients treated with Rechargeable Implantable Vagus Nerve Stimulation System (G114R)


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity of epilepsy detection [ Time Frame: 2-4 weeks after implant ]
    Sensitivity is defined as the total number of seizures detected divided by the total number of seizures during the EMU stay.

  2. False positives for epilepsy detection [ Time Frame: 2-4 weeks after implant ]
    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.


Secondary Outcome Measures :
  1. Changes in Seizure Frequency from Baseline [ Time Frame: up to 3 months Visit ]
    Seizure frequency is calculated at 2 and 3 month follow-up visits based on seizure diary information and compared to baseline estimates. Response rate is computed and summarized for seizure as the percentage of patients that achieved ≥50% seizure reduction per month from baseline by visit.

  2. Change in seizure Severity [ Time Frame: up to 3 months Visit ]
    The Epilepsy Severity Scale (NHS3) will be completed at baseline，at the end of the EMU phase and during the follow-up period. The severity of epilepsy will be assessed based on seizure type. The range of NHS3 scale is 1-27 with 1 being the least severe and 27 being the most severe.

  3. Change in Quality of Life [ Time Frame: up to 3 months Visit ]
    Quality of life data is collected using patient-completed QOLIE-31 scales and compared between baseline and follow-up visits. The range for QOLIE-31-P (all subscores) is 0-100 with higher scores reflecting greater well-being.

  4. Heart rate recording accuracy [ Time Frame: 1 to 2 weeks after implantation ]
    The total number and accuracy of heart rate detected by IPG are measured by ECG recording.

  5. Duty cycle [ Time Frame: up to 3 months Visit ]
    The total percentage of time VNS is on for an individual patient is called the duty cycle. It's calculated as (ON time + X )/(ON time + OFF time), X depended on the setting of Soft start/stop.

  6. Charging Equipment Satisfaction Evaluation [ Time Frame: 2-4 weeks after implant ]
    A questionnaire is used to evaluate the simplicity of the charging process and overall satisfaction.


Eligibility Criteria
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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • Patients currently enrolled in another investigational study;
  • Those deemed unsuitable by the researcher.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05993117


Contacts
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Contact: Jianguang Sun 010-60736388 sunjianguang@pinsmedical.com

Locations
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China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Ye Wu    010-66119025    bdyyec@163.com   
Sponsors and Collaborators
Beijing Pins Medical Co., Ltd
Peking University First Hospital
Beijing Tiantan Hospital
Investigators
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Principal Investigator: Ye Wu Peking University First Hospital
Principal Investigator: Jianguo Zhang Beijing Tiantan Hospital
More Information
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Responsible Party: Beijing Pins Medical Co., Ltd
ClinicalTrials.gov Identifier: NCT05993117    
Other Study ID Numbers: PINS-VNS-2101
First Posted: August 15, 2023    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Beijing Pins Medical Co., Ltd:
Vagus Nerve Stimulation
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases