Clinical Trial: CONCEPT: Crossover Efficacy Pain Trial in Motor Cortex Stimulation for Intractable Neuropathic Pain
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Prospective, Randomized, Double Blind, Crossover, Multi-center Study to Evaluate the Safety and the Efficacy of Motor Cortex Stimulation With the Cortical Stimulation Lead Model 2976 in Patients Wit
Brief Summary: The CONCEPT study has been designed to evaluate the safety and the efficacy of Motor Cortex Stimulation (MCS) with a new cortical lead (circular lead, eight electrodes, Medtronic Inc, Minneapolis, USA) in the treatment of intractable neuropathic pain, in particular for central post-stroke pain (CPSP) and trigeminal neuropathic pain (TGN)/facial pain.
Detailed Summary:
Sponsor: Medtronic
Current Primary Outcome:
- Adverse events reports
- Pain assessed by Visual Analogue Scale (VAS)
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Quality of life
- Disability
- Analgesic, sedative or psychoactive medication intake
Original Secondary Outcome: Same as current
Information By: Medtronic
Dates:
Date Received: July 21, 2005
Date Started: June 2005
Date Completion:
Last Updated: April 13, 2015
Last Verified: April 2015