Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 36 of 1353 for:    "Seizure Disorder"

Transcutaneous Auricular Vagus Nerve Stimulation for Pediatric Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02004340
Recruitment Status : Unknown
Verified February 2015 by Wei He, China Academy of Chinese Medical Sciences.
Recruitment status was:  Recruiting
First Posted : December 9, 2013
Last Update Posted : February 13, 2015
Sponsor:
Collaborators:
Beijing Tiantan Hospital
Beijing Children's Hospital
Information provided by (Responsible Party):
Wei He, China Academy of Chinese Medical Sciences

Tracking Information
First Submitted Date  ICMJE November 13, 2013
First Posted Date  ICMJE December 9, 2013
Last Update Posted Date February 13, 2015
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
frequency of epileptic seizures [ Time Frame: Change from baseline at 8, 16, 24 weeks respectively in frequency of epileptic seizures ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02004340 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
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" ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcutaneous Auricular Vagus Nerve Stimulation for Pediatric Epilepsy
Official Title  ICMJE Transcutaneous Auricular Vagus Nerve Stimulation as a Complementary Treatment for Pediatric Epilepsy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE Device: ear vagus nerve stimulator
Study Arms  ICMJE
  • Active Comparator: Transcutaneous auricular vagal stimulation
    Transcutaneous stimulation at auricular concha
    Intervention: Device: ear vagus nerve stimulator
  • Sham Comparator: Transcutaneous auricular non-vagal stimulation
    Transcutaneous stimulation at auricular edge
    Intervention: Device: ear vagus nerve stimulator
  • No Intervention: control
    No transcutaneous stimulation is given
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 3, 2013)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02004340
Other Study ID Numbers  ICMJE NSFC-81273829
2011CB505201 ( Other Grant/Funding Number: National Basic Resaearch Program (973 Program) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wei He, China Academy of Chinese Medical Sciences
Study Sponsor  ICMJE China Academy of Chinese Medical Sciences
Collaborators  ICMJE
  • Beijing Tiantan Hospital
  • Beijing Children's Hospital
Investigators  ICMJE
Study Director: Bing Zhu, Dr. Institute of Acupuncture and Moxibustion, CACMS
PRS Account China Academy of Chinese Medical Sciences
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP