Clinical Trial: Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Refractory Epilepsy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Refractory Epilepsy
Brief Summary: Evaluate the long-term clinical effectiveness and safety of the PINS Deep Brain Stimulation 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 evaluation period 6 month [ Time Frame: 6 month of stimulation ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Changes in seizure frequency from baseline to the seizure count evaluation period [ Time Frame: 1,3,6,12 months of stimulation ]
- 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 ]
- Change in the Number of Anti-epileptic Drugs Prescribed [ Time Frame: At 1,3,6,12 months ]
- Change from Baseline in the Engel and McHugh description [ Time Frame: At 1,3,6,12 months ]
Original Secondary Outcome: Same as current
Information By: Beijing Pins Medical Co., Ltd
Dates:
Date Received: October 10, 2015
Date Started: April 2015
Date Completion: December 2017
Last Updated: December 8, 2016
Last Verified: October 2016
