EpilepsyNCT02004340
Transcutaneous Auricular Vagus Nerve Stimulation for Pediatric Epilepsy
A study testing ear vagus nerve stimulator in people with Epilepsy, run by China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to determine whether transcutaneous auricular vagus nerve stimulation as a complementary therapy is effective in the treatment of pediatric epilepsy. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- ear vagus nerve stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Dec 2016
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Diagnosed as epilepsy;
- With age between 2-18 years old;
- The number and dose of the medication was kept constant no less than eight weeks before intervention;
- The patients or their guardians can count the frequency of the seizures and finish the study.
Who cannot join
- The patient is receiving the VNS therapy;
- Accompanied with progressive central nervous system diseases;
- Have severe heart, liver ,kidney or blood diseases;
- Be pregnant or having the schedule of pregnancy in the study period.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wei He
Beijing, 100700
Wei He, Dr., 86 10 64089403, hazel7811@hotmail.com
About this study
Official title: Transcutaneous Auricular Vagus Nerve Stimulation as a Complementary Treatment for Pediatric Epilepsy
The purpose of this study is to determine whether transcutaneous auricular vagus nerve stimulation as a complementary therapy is effective in the treatment of pediatric epilepsy.
- Conditions
- Epilepsy
- Being tested
- ear vagus nerve stimulator
- Keywords
- pediatric epilepsy, transcutaneous vagus nerve stimulation
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ear vagus nerve stimulatorDevice
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous auricular vagal stimulation | Active comparator | Transcutaneous stimulation at auricular concha Receives: Device: ear vagus nerve stimulator |
| Transcutaneous auricular non-vagal stimulation | Sham comparator | Transcutaneous stimulation at auricular edge Receives: Device: ear vagus nerve stimulator |
| control | No intervention | No transcutaneous stimulation is given |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of epileptic seizures
Measured: Change from baseline at 8, 16, 24 weeks respectively in frequency of epileptic seizures
Secondary outcomes (1)
Number of participants with adverse events as a measure of safety and tolerability
Measured: participants will be followed for the duration of TVNS intervention, an expected average of 8 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Beijing Children's Hospital
- Responsible party
- Principal investigator, Wei He, China Academy of Chinese Medical Sciences
- Investigators
- Bing Zhu, Dr., Study director, Institute of Acupuncture and Moxibustion, CACMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004340
- Sponsor's protocol ID
- NSFC-81273829
- Other IDs
- 2011CB505201
- Status last verified
- Feb 2015
- First submitted
- 13 Nov 2013
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
He W, Wang XY, Zhou L, Li ZM, Jing XH, Lv ZL, Zhao YF, Shi H, Hu L, Su YS, Zhu B. Transcutaneous auricular vagus nerve stimulation for pediatric epilepsy: study protocol for a randomized controlled trial. Trials. 2015 Aug 21;16:371. doi: 10.1186/s13063-015-0906-8.
PubMed 26292720
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation as a Complementary Treatment for Pediatric Epilepsy
- ClinicalTrials.gov ID
- NCT02004340
- Acronym / sponsor ID
- NSFC-81273829
- Conditions
- Epilepsy
- Keywords
- pediatric epilepsy, transcutaneous vagus nerve stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Beijing Children's Hospital
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Dec 2013 (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.
The purpose of this study is to determine whether transcutaneous auricular vagus nerve stimulation as a complementary therapy is effective in the treatment of pediatric epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous auricular vagal stimulation | Active comparator | Device: ear vagus nerve stimulatorTranscutaneous stimulation at auricular concha |
| Transcutaneous auricular non-vagal stimulation | Sham comparator | Device: ear vagus nerve stimulatorTranscutaneous stimulation at auricular edge |
| control | No intervention | –No transcutaneous stimulation is given |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosed as epilepsy;
- With age between 2-18 years old;
- The number and dose of the medication was kept constant no less than eight weeks before intervention;
- The patients or their guardians can count the frequency of the seizures and finish the study.
Key exclusion criteria (4 listed)
- The patient is receiving the VNS therapy;
- Accompanied with progressive central nervous system diseases;
- Have severe heart, liver ,kidney or blood diseases;
- Be pregnant or having the schedule of pregnancy in the study period.
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 |
|---|---|---|
| ear vagus nerve stimulator | Device | Transcutaneous auricular non-vagal stimulation, Transcutaneous auricular vagal stimulation |
Primary outcome
frequency of epileptic seizures
Time frame: Change from baseline at 8, 16, 24 weeks respectively in frequency of epileptic seizures
1 secondary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: participants will be followed for the duration of TVNS intervention, an expected average of 8 weeks"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2015.
- Derived from this study: PubMed 26292720He W, Wang XY, Zhou L, Li ZM, Jing XH, Lv ZL, Zhao YF, Shi H, Hu L, Su YS, Zhu B. Transcutaneous auricular vagus nerve stimulation for pediatric epilepsy: study protocol for a randomized controlled trial. Trials. 2015 Aug 21;16:371. doi: 10.1186/s13063-015-0906-8.
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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.
Bing Zhu, Dr. study director
Institute of Acupuncture and Moxibustion, CACMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ear vagus nerve stimulator in people with Epilepsy, run by China Academy of Chinese Medical Sciences 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 4 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 13 Feb 2015. 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 Wei He, Dr. (86 10 64089403, hazel7811@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of epileptic seizures (time frame: Change from baseline at 8, 16, 24 weeks respectively in frequency of epileptic seizures). 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 NCT02004340, 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 13 Feb 2015.