Transcutaneous Auricular Vagus Nerve Stimulation for Pediatric Epilepsy

NCT ID: NCT02004340

Last Updated: 2015-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Transcutaneous auricular vagal stimulation

Transcutaneous stimulation at auricular concha

Group Type ACTIVE_COMPARATOR

ear vagus nerve stimulator

Intervention Type DEVICE

Transcutaneous auricular non-vagal stimulation

Transcutaneous stimulation at auricular edge

Group Type SHAM_COMPARATOR

ear vagus nerve stimulator

Intervention Type DEVICE

control

No transcutaneous stimulation is given

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ear vagus nerve stimulator

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

Beijing Children's Hospital

OTHER

Sponsor Role collaborator

China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Wei He

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bing Zhu, Dr.

Role: STUDY_DIRECTOR

Institute of Acupuncture and Moxibustion, CACMS

Locations

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Wei He

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei He, Dr.

Role: CONTACT

86 10 64089403

Facility Contacts

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Wei He, Dr.

Role: primary

86 10 64089403

References

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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.

Reference Type DERIVED
PMID: 26292720 (View on PubMed)

Other Identifiers

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2011CB505201

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NSFC-81273829

Identifier Type: -

Identifier Source: org_study_id

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