Refractory EpilepsyNCT03062514
Trial to Evaluate the Safety and Effectiveness of Vagus Nerve Stimulation for Children With Refractory Epilepsy
A study testing PINS Vagus Nerve Stimualtor in people with Refractory Epilepsy, run by Beijing Pins Medical Co., Ltd at 1 site in China.
Trial summary
Children with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 2 arms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Refractory Epilepsy
- What is being tested?
- PINS Vagus Nerve Stimualtor
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2017to Dec 2019
- 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 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3-6
- At least 6 seizure per month
- Refractory Epilepsy
- In good health except epilepsy
- Patients or his(her) familyscould understand this method and sign the informed consent
- 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，bad health etc, and other surgical contraindication
- Cann't write the epilepsy diary
- Participating other clinical trial
- Cann't complate the operation
- Complete the postoperative follow-up
- Cann't complete the promgramming
Trial locations and contacts
1 site in 1 country.
Luming Li, PhD contact
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality
Yuwu Jiang, 010-83573228
About this study
Official title: Vagus Nerve Stimulation for Pediatric Intractable Epilepsy (VNS-PIE)
Children with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 2 arms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.
- Conditions
- Refractory Epilepsy
- Being tested
- PINS Vagus Nerve Stimualtor
- 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.
PINS Vagus Nerve StimualtorDevice
PINS Vagus Nerve Stimualtor
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Subjects'Vagus Nerve stimulator is on always Receives: Device: PINS Vagus Nerve Stimualtor |
| Control | Sham comparator | Subjects'Vagus Nerve stimulator is off from enrollment to 3 month Receives: Device: PINS Vagus Nerve Stimualtor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in seizure frequency
Measured: 12 weeks of stimulation
Secondary outcomes (4)
Changes in seizure frequency
Measured: 6、12、24 weeks of stimulation
Engel scale description
Measured: 6、12、24 weeks of stimulation
Changes in the Number of Anti-epileptic Drugs
Measured: 6、12、24 weeks of stimulation
GESELL mental development scales
Measured: 12、24 weeks of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start9 Oct 2017
- Primary completionJul 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuwu Jiang, MD, Principal investigator, Peking University First HospitalLiping Zou, Study director, Chinese PLA General HospitalJianxiang Liao, Study director, Shenzhen Children's HospitalQian Chen, Study director, Children's Hospital of The Capital Institute of PediatricsBaomin Li, Study director, Qilu Hospital of Shandong UniversityYuxing Gao, Study director, Shandong Provincial HospitalJianmin Liang, Study director, The First Hospital of Jilin UniversityShaoping Huang, Study director, Second Affiliated Hospital of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062514
- Sponsor's protocol ID
- PINS-026
- Status last verified
- Feb 2017
- First submitted
- 15 Feb 2017
- Last updated
- 2 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Panebianco M, Rigby A, Marson AG. Vagus nerve stimulation for focal seizures. Cochrane Database Syst Rev. 2022 Jul 14;7(7):CD002896. doi: 10.1002/14651858.CD002896.pub3.
PubMed 35833911Ji T, Yang Z, Liu Q, Liao J, Yin F, Chen Y, Zou L, Li B, Gao Y, Shu X, Huang S, Gao F, Liang J, Lin SF, Peng J, Song S, Wang J, Che C, Sun W, Tian M, Yang L, Hua Y, Hao Y, Cai L, Li L, Jiang Y. Vagus nerve stimulation for pediatric patients with intractable epilepsy between 3 and 6 years of age: study protocol for a double-blind, randomized control trial. Trials. 2019 Jan 14;20(1):44. doi: 10.1186/s13063-018-3087-4.
PubMed 30642370
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vagus Nerve Stimulation for Pediatric Intractable Epilepsy (VNS-PIE)
- ClinicalTrials.gov ID
- NCT03062514
- Acronym / sponsor ID
- PINS-026
- Conditions
- Refractory Epilepsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 23 Feb 2017 (actual)
- 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.
Children with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 2 arms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: PINS Vagus Nerve StimualtorSubjects'Vagus Nerve stimulator is on always |
| Control | Sham comparator | Device: PINS Vagus Nerve StimualtorSubjects'Vagus Nerve stimulator is off from enrollment to 3 month |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 3-6
- At least 6 seizure per month
- Refractory Epilepsy
- In good health except epilepsy
- Patients or his(her) familyscould understand this method and sign the informed consent
Key exclusion criteria (8 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，bad health etc, and other surgical contraindication
- Cann't write the epilepsy diary
- Participating other clinical trial
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 |
|---|---|---|
| PINS Vagus Nerve StimualtorPINS Vagus Nerve Stimualtor | Device | Control, Experimental |
Primary outcome
Changes in seizure frequency
Time frame: 12 weeks of stimulation
4 secondary outcomes
Changes in seizure frequency
Time frame: 6、12、24 weeks of stimulation
Engel scale description
Time frame: 6、12、24 weeks of stimulation
Changes in the Number of Anti-epileptic Drugs
Time frame: 6、12、24 weeks of stimulation
GESELL mental development scales
Time frame: 12、24 weeks of stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Derived from this study: PubMed 35833911Panebianco M, Rigby A, Marson AG. Vagus nerve stimulation for focal seizures. Cochrane Database Syst Rev. 2022 Jul 14;7(7):CD002896. doi: 10.1002/14651858.CD002896.pub3.
- Derived from this study: PubMed 30642370Ji T, Yang Z, Liu Q, Liao J, Yin F, Chen Y, Zou L, Li B, Gao Y, Shu X, Huang S, Gao F, Liang J, Lin SF, Peng J, Song S, Wang J, Che C, Sun W, Tian M, Yang L, Hua Y, Hao Y, Cai L, Li L, Jiang Y. Vagus nerve stimulation for pediatric patients with intractable epilepsy between 3 and 6 years of age: study protocol for a double-blind, randomized control trial. Trials. 2019 Jan 14;20(1):44. doi: 10.1186/s13063-018-3087-4.
- Individual participant dataSharing planned: Undecided
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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.
Luming Li, PhD contact
Yuwu Jiang, MD principal investigator
Peking University First Hospital
Liping Zou study director
Chinese PLA General Hospital
Jianxiang Liao study director
Shenzhen Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PINS Vagus Nerve Stimualtor in people with 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 6 inclusion and 8 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 2 Jan 2018. 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. 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.
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 Fumin Jia, PhD (010-60736388, pins_medical@163.con), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in seizure frequency (time frame: 12 weeks 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 NCT03062514, which also lists 2 linked publications.
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 2 Jan 2018.