Clinical Trial: Motor Cortex Stimulation for Chronic Neuropathic Pain

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Clinical Evaluation for the Management of Patients With Chronic Neuropathic Pain With Cortical Stimulation

Brief Summary: The purpose of this study is to evaluate the efficacy of cortical stimulation (CS) as an adjunctive treatment for chronic neuropathic pain.

Detailed Summary: Prospective, controlled, double blind, randomized, crossover study with endpoint evaluations at the end of each 3-month treatment period.
Sponsor: St. Jude Medical

Current Primary Outcome: Visual Analog Scale (VAS) [ Time Frame: Approximately 7 months ]

The primary analysis of effectiveness is based on the mean differences in changes from the period-specific baseline in VAS scores when patients are receiving 3 month of active vs. 3 months of sham stimulation on a double-blinded fashion.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Visual Analog Scale, responder [ Time Frame: Participants will be followed for approximatley 18 months ]
    defined as a ≥30% or 2 points reduction from baseline in VAS scores
  • Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Participants will be followed for approximatley 18 months ]
  • Brief Pain Inventory (BPI) [ Time Frame: Participants will be followed for approximatley 18 months ]
  • Short Form of the McGill Pain Questionnaire(SF-MPQ) [ Time Frame: Participants will be followed for approximatley 18 months ]
  • Sickness Impact Profile (SIP) [ Time Frame: Participants will be followed for approximatley 18 months ]
  • Medication Quantification Scale (MQS) [ Time Frame: Participants will be followed for approximatley 18 months ]
  • SF-36 Health Survey and safety [ Time Frame: Participants will be followed for approximatley 18 months ]
  • Pain Catastrophizing Scale (PCS) [ Time Frame: Participants will be followed for approximatley 18 months ]
  • Global Impression of Change (patient and evaluator's version) [ Time Frame: Participants will be followed for approximatley 18 months ]
  • Device related Adverse Events [ Time Frame: Participants will be followed for approximatley 18 months ]


Original Secondary Outcome: Same as current

Information By: St. Jude Medical

Dates:
Date Received: January 13, 2012
Date Started: October 2012
Date Completion: December 2018
Last Updated: April 24, 2017
Last Verified: April 2017