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Drug-Refractory EpilepsyNCT05993117

Rechargeable Implantable Vagus Nerve Stimulation System for Drug-Refractory Epilepsy

A study testing G114R VNS system in people with Drug-Refractory Epilepsy, run by Beijing Pins Medical Co., Ltd at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 3 years and older
Conditions the study is for
Drug-Refractory Epilepsy
What is being tested?
G114R VNS system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Sep 2021to Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

Jianguang Sun contact

010-60736388

sunjianguang@pinsmedical.com

China1 site, 1 recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Ye Wu, 010-66119025, bdyyec@163.com

    Recruiting

Other trials in China

About this study

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

Read the 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.

Being tested
G114R VNS system
Keywords
Vagus Nerve Stimulation
Medical subject headings
Drug Resistant Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • G114R VNS systemDevice

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

Study groups in NCT05993117
Study groupRoleWhat they receive
G114R VNS systemExperimentalNot described
Receives: Device: G114R VNS system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2-4 weeks after implant

  2. 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.

    Measured: 2-4 weeks after implant

Secondary outcomes (6)

  1. Changes in Seizure Frequency from Baseline

    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.

    Measured: up to 3 months Visit

  2. Change in seizure Severity

    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.

    Measured: up to 3 months Visit

  3. Change in Quality of Life

    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.

    Measured: up to 3 months Visit

  4. Heart rate recording accuracy

    The total number and accuracy of heart rate detected by IPG are measured by ECG recording.

    Measured: 1 to 2 weeks after implantation

  5. Duty cycle

    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.

    Measured: up to 3 months Visit

  6. Charging Equipment Satisfaction Evaluation

    A questionnaire is used to evaluate the simplicity of the charging process and overall satisfaction.

    Measured: 2-4 weeks after implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2023
  2. Study start1 Sep 2021
  3. Primary completionJun 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05993117
Sponsor's protocol ID
PINS-VNS-2101
Status last verified
Sep 2023
First submitted
28 Jul 2023
Last updated
13 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing G114R VNS system in people with Drug-Refractory Epilepsy, run by Beijing Pins Medical Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jianguang Sun (010-60736388, sunjianguang@pinsmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity of epilepsy detection (time frame: 2-4 weeks after implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05993117.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.

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