Clinical Trial: Clinical Trial of Vagus Nerve Stimulation for Treatment of Refractory Epilepsy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Clinical Research on TsingHua Vagus Nerve Stimualtor for Treatment of Refractory Epilepsy

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

Detailed Summary:
Sponsor: Beijing Pins Medical Co., Ltd

Current Primary Outcome: 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 ]

Original Primary Outcome: Changes in seizure frequency from baseline to the seizure count evaluvation period 6 month [ Time Frame: 6 month of stimulation ]

Current Secondary Outcome:

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


Original Secondary Outcome:

  • Changes in seizure frequency from baseline to the seizure count evaluvation period [ Time Frame: 1,3,6,12 months of stimulation ]
    Changes in seizure frequency from baseline to 1,3,6,12 months
  • 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 1,3,6,12 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.
  • Changes in the Number of Anti-epileptic Drugs Prescribed [ Time Frame: At 1,3,6 12 months ]
    Changes in Anti-Epileptic Drugs (AEDs) in patients with less then a 50% reduction in seizures
  • Change fron Basline in the Engel and McHugh description [ Time Frame: At 1,3,6 12 months ]


Information By: Beijing Pins Medical Co., Ltd

Dates:
Date Received: February 27, 2015
Date Started: August 2014
Date Completion: December 2017
Last Updated: October 11, 2016
Last Verified: April 2016