Rechargeable implantable device for treating drug-resistant epilepsy
Rechargeable Implantable Vagus Nerve Stimulation System for Drug-Refractory Epilepsy
This study is testing a new rechargeable device that stimulates the vagus nerve to see if it can help people with hard-to-treat epilepsy have fewer seizures and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 3 Years and up |
| Sex | All |
| Sponsor | Beijing Pins Medical Co., Ltd Industry-sponsored |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05993117 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a new rechargeable implantable vagus nerve stimulation system designed for patients with drug-refractory epilepsy. It is a prospective, single-group, open-label trial that collects data on patients implanted with the Model G114R VNS system. Participants will undergo a stay in an epilepsy monitoring unit for up to 5 days, followed by a 3-month follow-up to assess seizure frequency and quality of life, while also monitoring for any adverse events.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 3 years and older with clinically diagnosed drug-resistant epilepsy experiencing at least 6 seizures per month.
Not a fit: Patients who do not have drug-resistant epilepsy or those who do not meet the specific inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly reduce seizure frequency and improve the quality of life for patients with drug-refractory epilepsy.
How similar studies have performed: Other studies have shown success with vagus nerve stimulation for epilepsy, indicating that this approach has been tested and has potential benefits.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing
- Peking University First Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Ye Wu — Peking University First Hospital
- Study coordinator: Jianguang Sun
- Email: sunjianguang@pinsmedical.com
- Phone: 010-60736388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.