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Trial record 37 of 1463 for:    "Epilepsy"

Clinical Trial of Vagus Nerve Stimulation for Treatment of Refractory Epilepsy (VNSRE)

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ClinicalTrials.gov Identifier: NCT02378792
Recruitment Status : Unknown
Verified April 2016 by Beijing Pins Medical Co., Ltd.
Recruitment status was:  Recruiting
First Posted : March 4, 2015
Last Update Posted : October 12, 2016
Sponsor:
Collaborator:
Beijing Tiantan Hospital
Information provided by (Responsible Party):
Beijing Pins Medical Co., Ltd

Brief Summary:
Evaluate the long-term clinical effectiveness and safety of the PINS vagus nerve stimulator to patients with refractory epilepsy.

Condition or disease Intervention/treatment Phase
Refractory Epilepsy Device: Vagus Nerve Stimulation Early Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Clinical Research on TsingHua Vagus Nerve Stimualtor for Treatment of Refractory Epilepsy
Study Start Date : August 2014
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: Vagus Verve Stimulation is on Device: Vagus Nerve Stimulation
Vagus Nerve Stimulator
Other Name: PINS Stimulator System

Sham Comparator: Placebo Vagus Verve Stimulation is off Device: Vagus Nerve Stimulation
Vagus Nerve Stimulator
Other Name: PINS Stimulator System




Primary Outcome Measures :
  1. Changes in seizure frequency from baseline to the seizure count evaluvation period 6 month [ Time Frame: 4,8,12,16,20,24 months of stimulation ]

Secondary Outcome Measures :
  1. Changes in seizure frequency from baseline to the seizure count evaluvation period [ Time Frame: 4,8,12,16,20,24 months of stimulation ]
    Changes in seizure frequency from baseline to 4,8,12,16,20,24 months

  2. Overall Quality of Life in Epilepsy-31 (QOLIE-31) Score in Patients With Baseline & at Least One Post-baseline QOLIE Assessment [ Time Frame: Mean change from baseline QOLIE-31 Overall Score at 12,24 months ]
    QOLIE-31 contains 7 multi-item scales that tap the following health concepts:overall quality of life, emotional well-being, social functioning, energy/fatigue, worry about seizure,cognitive functioning,medication effects. Range of values 0-100. Higher scores reflect better quality of life; lower ones, worse quality of life.

  3. Changes in the Number of Anti-epileptic Drugs Prescribed [ Time Frame: At12,24 months ]
    Changes in Anti-Epileptic Drugs (AEDs) in patients with less then a 50% reduction in seizures

  4. Changes from Basline in the Engel and McHugh description [ Time Frame: At 12,24 months ]
  5. Changes from Basline in 24 hour ECG description [ Time Frame: At 12,24 months ]


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Ages Eligible for Study:   6 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 6-60.
  2. Having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose.
  3. At least 1 seizure per month.
  4. In good health except epilepsy.
  5. With normal MMSE score
  6. Patients or his(her) familyscould understand this method and sign the informed consent 7)Patients with good compliance and could complete postoperative follow-up.

Exclusion Criteria:

  1. Results of MRI remind epilepsy caused by intracranial space-occupying lesions.
  2. The vagus nerve lesion and damage
  3. Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma,mental disease,pepticulcer,diabetes Type 1,bad health etc, and other surgical contraindication
  4. Alcohol addiction, smoking, and sleep-related breathing disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02378792


Contacts
Contact: Jia Fumin, PhD +86 010-59361265 pins_medical@163.com
Contact: Li Luming, PhD +86 010-60736388

Locations
China, Beijing
Beijing Tiantan Hospital Recruiting
Beijing, Beijing, China, 100050
Contact: Jianguo Zhang, MD    010-67096611    Limuxin2011@163.com   
China, Jilin
The first hospital of jilin university Recruiting
Changchun, Jilin, China, 130021
Contact: Kan Xu, MD         
Contact: Jiqing Qiu         
China, Liaoning
The general of shenyang military Recruiting
Shenyang, Liaoning, China, 110011
Contact: Guobiao Liang, MD         
Contact: Guanqian Yuan         
China, Shandong
Qilu hospital of shandong university Recruiting
Jinan, Shandong, China, 250012
Contact: Shujun Xu, MD         
Contact: Wenhua Zhang         
China, Zhejiang
The second affiliated hospital zhejiang university school of medicine Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Weiming FU, MD         
Contact: Junming Zhu         
Sponsors and Collaborators
Beijing Pins Medical Co., Ltd
Beijing Tiantan Hospital

Responsible Party: Beijing Pins Medical Co., Ltd
ClinicalTrials.gov Identifier: NCT02378792     History of Changes
Other Study ID Numbers: PINS-012
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: April 2016

Keywords provided by Beijing Pins Medical Co., Ltd:
PINS VNS Refractory Epilepsy

Additional relevant MeSH terms:
Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases