Clinical Trial of Rechargeable Implantable Vagus Nerve Stimulation System for Refractory Epilepsy
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the performance and safety of the rechargeable implantable vagus nerve stimulation system in automatic mode, and the clinical efficacy and safety of the device in the treatment of drug-resistant epilepsy with all modes of stimulation turned on
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This clinical trial is using a single experimental group ,unblindedstudy designed to collect data on patients implanted with a G114R VNS Therapy System from baseline through an EMU stay . After the EMU stay, patients will continue follow-up for safety and effectiveness for approximately 3 months or until final regulatory approval of the product.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Model G114R VNS Therapy System Model G114R VNS Therapy System includes a new stimulation mode, Automatic Mode. |
Device: PINS Vagus Nerve Stimulator
Model G114R VNS Therapy System includeds a automatic mode.
|
Outcome Measures
Primary Outcome Measures
- Sensitivity to epilepsy detection [1 to 5 days after normal mode stimulation]
Sensitivity was defined as the ratio of the total number of seizures detected by the implanted device during the EMU phase to the total number of seizures reported by the investigator. Sensitivity is reported only when heart rate exceeds a set detection threshold.
- False positives for epilepsy detection [1 to 5 days after normal mode stimulation]
Seizure detection false positive, for detection of implanted devices outside the ±2min time window of detected seizures by the EEG monitoring device and triggering automatic mode stimulation.
Secondary Outcome Measures
- Changes From Baseline in Seizure Frequency [up to 3 months Visit]
Seizure frequency was calculated at 2 and 3 month follow-up visits based on seizure diary information and compared to baseline estimates. Response rate was computed and summarized for seizure as the percentage of patients that achieved ≥50% seizure reduction per month from baseline by visit.
- Epilepsy Severity Scale (NHS3) [up to 3 months Visit]
The researchers completed the Epilepsy Severity Scale (NHS3) at baseline，at the end of the EMU phase and at follow-up. Severity was assessed by seizure type. The NHS3 scale ranged from 1 to 27, with 1 being the least severe and 27 being the most severe.
- Quality of Life Scale for patients with epilepsy -QOLIE-31 [up to 3 months Visit]
Quality of life data were collected using patient-completed QOLIE-31 scales and compared at baseline and follow-up with qolie-31-P (all subscores) ranging from 0 to 100, with higher scores reflecting better well-being (criteria: subjects able to read and understand the questions).
- Heart rate verification [up to 3 months Visit]
The total number and accuracy of accurately detected heartbeats in the entire study population were reported using data from an implantable pulse generator (IPG) and ECG.
- Stimulation time duty cycle [up to 3 months Visit]
Duty cycle (percentage of pulse generator output stimulation time) = stimunlation time/total start up time of pulse generator; If soft start is turned on, stimunlation time= turn on time + soft start time + soft stop time.
- Test instrument evaluation questionnaire [up to 3 months Visit]
To collect usability data, satisfaction data for evaluating rechargeable implantable vagal nerve stimulation systems using a hand-held programmer. Measure usability, ranging from "extremely easy" to "very difficult," expressed as the percentage of users who rated usability as "easy" and "extremely easy." Satisfaction is measured, ranging from "Very Satisfied" to "Very Dissatisfied", expressed by the proportion of users who evaluate satisfaction as "Very Satisfied" and "Satisfied".
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age: ≥3 years old; gender is not limited;
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Patients with clinically diagnosed drug-resistant epilepsy, suitable for vagus nerve stimulation therapy;
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Patients with epileptic seizures ≥6 times per month;
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Patients with increased heart rate associated with seizures based on clinical data obtained from past medical history, admission/hospitalization records, or previous neurophysiological assessments;
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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-to-peak value of the R wave of the ECG should be higher than 0.40mV;
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Patients who are willing to undergo epilepsy monitoring unit phase assessment and activate the automatic mode function during this period;
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The patient must have good general health and ambulatory status;
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Children and guardians with the ability to give informed consent must be willing and able to complete informed consent;
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The patients and their families have good compliance and can cooperate with the completion of postoperative follow-up requirements.
Exclusion Criteria:
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Patients who have undergone bilateral or left cervical vagotomy;
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One or both sides of the vagus nerve itself have lesions or damage;
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The patient had a history of VNS treatment;
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Patients with a history of status epilepticus within 1 year before study enrollment;
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Patients with a history of mental illness or pseudoepileptic seizures or epilepsy caused by intracranial space-occupying lesions;
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Currently using or expecting to use short-wave diathermy, microwave diathermy or therapeutic ultrasonic diathermy;
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Whole-body magnetic resonance imaging is expected in the patient;
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VNS therapeutic system implants will bring unacceptable surgical or medical risks to patients (according to the judgment of the investigator);
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Surgical contraindications identified by surgeons and anesthesiologists such as tumors, insulin-dependent diabetes mellitus or poor general condition;
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Recording of clinically significant seizure-related bradycardia (heart rate below 50 bpm);
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The patient is taking drugs that may affect heart rate response, such as drugs for the treatment of heart disease or autonomic disorders, including but not limited to beta-adrenergic antagonists ("beta-blockers");
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Patients with known clinically significant arrhythmias, and patients with clinically significant arrhythmias identified by 24-hour ambulatory ECG recordings obtained at the screening visit;
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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;
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Patients who abuse alcohol or use narcotic drugs;
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Pregnant women, lactating women, and women of childbearing age must undergo pregnancy examinations;
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Patients currently undergoing another study;
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Those deemed unsuitable by the researcher.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University First Hospital | Beijing | Beijing | China | 100034 |
Sponsors and Collaborators
- Beijing Pins Medical Co., Ltd
- Peking University First Hospital
- Beijing Tiantan Hospital
Investigators
- Principal Investigator: Ye Wu, Peking University First Hospital
- Principal Investigator: Jianguo Zhang, Beijing Tiantan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PINS-VNS-2101