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