Epileptic EncephalopathyNCT02603991
Prospective Cohort Study on the Efficacy of Vagus Nerve Stimulation for Children and Adolescents With Epilepsy(PVNS-CAE)
An observational study of Epileptic Encephalopathy, run by Beijing Pins Medical Co., Ltd at 1 site in China.
Trial summary
Prospective cohort study on the long-term effectiveness and safety of PINS vagus nerve stimulators for children and adolescent with refractory epilepsy. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Epileptic Encephalopathy
- What is being tested?
- PINS Vagus Nerve Stimulator and Levetiracetam
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Oct 2017
- Phase
- Observational
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients at age 4-18; diagnostic criteria for epilepsia brain disorders; having tried appropriate anti-epileptic drugs (AEDs) more than 1 year and at least 6 seizures per month; patients or his(her) familys could understand this method and sign the informed consent; Patients with good compliance and could complete postoperative follow-up；without the vagus nerve lesion and damagement, progressive neurological diseases, cardiopulmonary anomaly, respiratory system diseases, digestive system diseases
Who may be able to join
- age 4-18
- Diagnostic criteria for epilepsia brain disorders
- Having tried appropriate anti-epileptic drugs (AEDs) more than 1 year and zt least 6 seizures per month
- patients or his(her) families could understand this method and sign the informed consent
- Patients with good compliance and could complete postoperative follow-up
Who cannot join
- the vagus nerve lesion and damage
- patients with progressive neurological diseases, cardiopulmonary anomaly, respiratory system diseases,digestive system diseases
- patients'mental state is not stable，
- patients with or anesthesia contraindications,such as long-term use of anticoagulation antiplatelet drugs etc.
- patients have or need other implantable devices, such as pacemakers,defibrillators, cochlear and spinal nerve root stimulator.
- patients due to their own reasons for the need for nuclear magnetic resonance imaging in the future clinical trials
- patients have participated in other clinical trials.
Trial locations and contacts
1 site in 1 country.
Fumin Jia, PhD contact
Luming Li, PhD contact
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100050
Jianguo Zhang, MD, 010-67096611, Limuxin2011@163.com
About this study
Prospective cohort study on the long-term effectiveness and safety of PINS vagus nerve stimulators for children and adolescent with refractory epilepsy.
Read the detailed description
Epileptic encephalopathy is very common in children and adolescent with epilepsy, but there is no data in clinical studies.The aim of this study is to evaluate the efficacy of the long-term vagus nerve stimulation for children and adolescent with epilepsy
- Conditions
- Epileptic Encephalopathy
- Being tested
- PINS Vagus Nerve Stimulator, Levetiracetam
- Keywords
- children and adolescents, Prospective cohort study, vagus nerve stimulation, PINS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PINS Vagus Nerve StimulatorProcedure or surgery
The stimulators are implanted in the body,with the stimulation of the IPG
LevetiracetamDrug
The best anti-epileptic drugs to patients who participate in this study，Levetiracetam，
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of the score in Quality of Life in Children with Epilepsy
Measured: QOLCE Scores at 3,6,9,12,18, 24 month of stimulation
Secondary outcomes (3)
Respondent rate
Measured: Respondent rate at 3,6,9,12,24 month
seizure free rate
Measured: seizure free rate at 3,6,9,12, 24 month
complication
Measured: complication at 3,6,9,12, 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startJun 2016
- Primary completionJan 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epileptic EncephalopathyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianguo Zhang, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603991
- Sponsor's protocol ID
- PINS-015
- Status last verified
- Oct 2016
- First submitted
- 9 Nov 2015
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on the Efficacy of Vagus Nerve Stimulation for Children and Adolescents With Epilepsy(PVNS-CAE)
- ClinicalTrials.gov ID
- NCT02603991
- Acronym / sponsor ID
- PINS-015
- Conditions
- Epileptic Encephalopathy
- Keywords
- children and adolescents, Prospective cohort study, vagus nerve stimulation, PINS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 13 Nov 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.
Prospective cohort study on the long-term effectiveness and safety of PINS vagus nerve stimulators for children and adolescent with refractory epilepsy.
Detailed description
Epileptic encephalopathy is very common in children and adolescent with epilepsy, but there is no data in clinical studies.The aim of this study is to evaluate the efficacy of the long-term vagus nerve stimulation for children and adolescent with epilepsy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients at age 4-18; diagnostic criteria for epilepsia brain disorders; having tried appropriate anti-epileptic drugs (AEDs) more than 1 year and at least 6 seizures per month; patients or his(her) familys could understand this method and sign the informed consent; Patients with good compliance and could complete postoperative follow-up；without the vagus nerve lesion and damagement, progressive neurological diseases, cardiopulmonary anomaly, respiratory system diseases, digestive system diseases
Key inclusion criteria (5 listed)
- age 4-18
- Diagnostic criteria for epilepsia brain disorders
- Having tried appropriate anti-epileptic drugs (AEDs) more than 1 year and zt least 6 seizures per month
- patients or his(her) families could understand this method and sign the informed consent
- Patients with good compliance and could complete postoperative follow-up
Key exclusion criteria (7 listed)
- the vagus nerve lesion and damage
- patients with progressive neurological diseases, cardiopulmonary anomaly, respiratory system diseases,digestive system diseases
- patients'mental state is not stable，
- patients with or anesthesia contraindications,such as long-term use of anticoagulation antiplatelet drugs etc.
- patients have or need other implantable devices, such as pacemakers,defibrillators, cochlear and spinal nerve root stimulator.
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 StimulatorThe stimulators are implanted in the body,with the stimulation of the IPG | Procedure or surgery | – |
| LevetiracetamThe best anti-epileptic drugs to patients who participate in this study，Levetiracetam， | Drug | – |
Primary outcome
The change of the score in Quality of Life in Children with Epilepsy
Time frame: QOLCE Scores at 3,6,9,12,18, 24 month of stimulation
3 secondary outcomes
Respondent rate
Time frame: Respondent rate at 3,6,9,12,24 month
seizure free rate
Time frame: seizure free rate at 3,6,9,12, 24 month
complication
Time frame: complication at 3,6,9,12, 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
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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.
Fumin Jia, PhD contact
Luming Li, PhD contact
Jianguo Zhang, MD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epileptic Encephalopathy, 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 5 inclusion and 7 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 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 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 Fumin Jia, PhD (+86-010-59361265), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of the score in Quality of Life in Children with Epilepsy (time frame: QOLCE Scores at 3,6,9,12,18, 24 month of stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2016.