Refractory EpilepsyEarly Phase 1VNSRENCT02378792
Clinical Trial of Vagus Nerve Stimulation for Treatment of Refractory Epilepsy
A Early Phase 1 study testing Vagus Nerve Stimulation in people with Refractory Epilepsy, run by Beijing Pins Medical Co., Ltd at 5 sites in China.
Trial summary
Evaluate the long-term clinical effectiveness and safety of the PINS vagus nerve stimulator to patients with refractory epilepsy. Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- Refractory Epilepsy
- What is being tested?
- Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 5 sitesChina
- Study dates
- Aug 2014to Dec 2017
- Phase
- Early Phase 1
- 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 6 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 6-60.
- Having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose.
- At least 1 seizure per month.
- In good health except epilepsy.
- With normal MMSE score
- Patients or his(her) familyscould understand this method and sign the informed consent 7）Patients with good compliance and could complete postoperative follow-up.
Who cannot join
- Results of MRI remind epilepsy caused by intracranial space-occupying lesions.
- The vagus nerve lesion and damage
- Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，pepticulcer，diabetes Type 1，bad health etc, and other surgical contraindication
- Alcohol addiction, smoking, and sleep-related breathing disorders
Trial locations and contacts
5 sites in 1 country.
Li Luming, PhD contact
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050
Jianguo Zhang, MD, 010-67096611, Limuxin2011@163.com
- Recruiting
The first hospital of jilin university
Changchun, Jilin, 130021
Kan Xu, MD
Jiqing Qiu
- Recruiting
The second affiliated hospital zhejiang university school of medicine
Hangzhou, Zhejiang, 310009
Weiming FU, MD
Junming Zhu
- Recruiting
Qilu hospital of shandong university
Jinan, Shandong, 250012
Shujun Xu, MD
Wenhua Zhang
- Recruiting
The general of shenyang military
Shenyang, Liaoning, 110011
Guobiao Liang, MD
Guanqian Yuan
About this study
Official title: The Clinical Research on TsingHua Vagus Nerve Stimualtor for Treatment of Refractory Epilepsy
Evaluate the long-term clinical effectiveness and safety of the PINS vagus nerve stimulator to patients with refractory epilepsy.
- Conditions
- Refractory Epilepsy
- Being tested
- Vagus Nerve Stimulation
- Keywords
- PINS VNS Refractory Epilepsy
- 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.
Vagus Nerve StimulationDevice
Also called PINS Stimulator System
Vagus Nerve Stimulator
| Study group | Role | What they receive |
|---|---|---|
| Vagus Verve Stimulation is on | Experimental | Not described Receives: Device: Vagus Nerve Stimulation |
| Placebo Vagus Verve Stimulation is off | Sham comparator | Not described Receives: Device: Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in seizure frequency from baseline to the seizure count evaluvation period 6 month
Measured: 4,8,12,16,20,24 months of stimulation
Secondary outcomes (5)
Changes in seizure frequency from baseline to the seizure count evaluvation period
Changes in seizure frequency from baseline to 4,8,12,16,20,24 months
Measured: 4,8,12,16,20,24 months of stimulation
Overall Quality of Life in Epilepsy-31 (QOLIE-31) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment
QOLIE-31 contains 7 multi-item scales that tap the following health concepts:overall quality of life, emotional well-being, social functioning, energy/fatigue, worry about seizure,cognitive functioning,medication effects. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life.
Measured: Mean change from baseline QOLIE-31 Overall Score at 12,24 months
Changes in the Number of Anti-epileptic Drugs Prescribed
Changes in Anti-Epileptic Drugs (AEDs) in patients with less then a 50% reduction in seizures
Measured: At12,24 months
Changes from Basline in the Engel and McHugh description
Measured: At 12,24 months
Changes from Basline in 24 hour ECG description
Measured: At 12,24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startAug 2014
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractory EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378792
- Sponsor's protocol ID
- PINS-012
- Acronym
- VNSRE
- Status last verified
- Apr 2016
- First submitted
- 27 Feb 2015
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu H, Zhan P, Meng F, Wang W. Chronic vagus nerve stimulation for drug-resistant epilepsy may influence fasting blood glucose concentration. Biomed Eng Online. 2020 May 29;19(1):40. doi: 10.1186/s12938-020-00784-1.
PubMed 32471438
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Research on TsingHua Vagus Nerve Stimualtor for Treatment of Refractory Epilepsy
- ClinicalTrials.gov ID
- NCT02378792
- Acronym / sponsor ID
- VNSRE / PINS-012
- Conditions
- Refractory Epilepsy
- Keywords
- PINS VNS Refractory Epilepsy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital
- Study start
- Aug 2014
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the long-term clinical effectiveness and safety of the PINS vagus nerve stimulator to patients with refractory epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vagus Verve Stimulation is on | Experimental | Device: Vagus Nerve Stimulation |
| Placebo Vagus Verve Stimulation is off | Sham comparator | Device: Vagus Nerve Stimulation |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 6-60.
- Having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose.
- At least 1 seizure per month.
- In good health except epilepsy.
- With normal MMSE score
Key exclusion criteria (4 listed)
- Results of MRI remind epilepsy caused by intracranial space-occupying lesions.
- The vagus nerve lesion and damage
- Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，pepticulcer，diabetes Type 1，bad health etc, and other surgical contraindication
- Alcohol addiction, smoking, and sleep-related breathing disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagus Nerve StimulationAlso: PINS Stimulator SystemVagus Nerve Stimulator | Device | Placebo Vagus Verve Stimulation is off, Vagus Verve Stimulation is on |
Primary outcome
Changes in seizure frequency from baseline to the seizure count evaluvation period 6 month
Time frame: 4,8,12,16,20,24 months of stimulation
5 secondary outcomes
Changes in seizure frequency from baseline to the seizure count evaluvation period
Time frame: 4,8,12,16,20,24 months of stimulation
Overall Quality of Life in Epilepsy-31 (QOLIE-31) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment
Time frame: Mean change from baseline QOLIE-31 Overall Score at 12,24 months
Changes in the Number of Anti-epileptic Drugs Prescribed
Time frame: At12,24 months
Changes from Basline in the Engel and McHugh description
Time frame: At 12,24 months
Changes from Basline in 24 hour ECG description
Time frame: At 12,24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Derived from this study: PubMed 32471438Liu H, Zhan P, Meng F, Wang W. Chronic vagus nerve stimulation for drug-resistant epilepsy may influence fasting blood glucose concentration. Biomed Eng Online. 2020 May 29;19(1):40. doi: 10.1186/s12938-020-00784-1.
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Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Luming, PhD contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vagus Nerve Stimulation in people with Refractory Epilepsy, run by Beijing Pins Medical Co., Ltd at 5 sites 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 6 inclusion and 4 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 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jia Fumin, PhD (+86 010-59361265, pins_medical@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in seizure frequency from baseline to the seizure count evaluvation period 6 month (time frame: 4,8,12,16,20,24 months of stimulation). 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 NCT02378792, which also lists 1 linked publication.
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 12 Oct 2016.