NCT02004340

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2013

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 13, 2015

Status Verified

February 1, 2015

Enrollment Period

2.1 years

First QC Date

November 13, 2013

Last Update Submit

February 12, 2015

Conditions

Epilepsy

Keywords

pediatric epilepsytranscutaneous vagus nerve stimulation

Outcome Measures

Primary Outcomes (1)

  • frequency of epileptic seizures

    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

    participants will be followed for the duration of TVNS intervention, an expected average of 8 weeks"

Study Arms (3)

Transcutaneous auricular vagal stimulation

ACTIVE COMPARATOR

Transcutaneous stimulation at auricular concha

Device: ear vagus nerve stimulator

Transcutaneous auricular non-vagal stimulation

SHAM COMPARATOR

Transcutaneous stimulation at auricular edge

Device: ear vagus nerve stimulator

control

NO INTERVENTION

No transcutaneous stimulation is given

Interventions

ear vagus nerve stimulatorDEVICE
Transcutaneous auricular non-vagal stimulationTranscutaneous auricular vagal stimulation

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wei He

Beijing, 100700, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26292720DERIVED

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Bing Zhu, Dr.

    Institute of Acupuncture and Moxibustion, CACMS

    STUDY DIRECTOR

Central Study Contacts

Wei He, Dr.

CONTACT

86 10 64089403hazel7811@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 13, 2013

First Posted

December 9, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

February 13, 2015

Record last verified: 2015-02

Locations

CN(1)