Clinical Trial: PINS Stimulator System for Deep Brain Stimulation of the Nucleus Accumbens to Treat Severe Opioid Addiction

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: PINS Stimulator System for Deep Brain Stimulation of the Nucleus Accumbens to Treat Severe Opioid Addiction

Brief Summary: The purpose of this study is to verify efficacy and safety of a bilateral deep brain stimulation (DBS) of the Nucleus accumbens (NAc) as a treatment option for severe opioid addiction.

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

Current Primary Outcome: Schedule for the Assessment of Negative Symptoms (SANS) [ Time Frame: 6 month ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Chronic Hunger Scale [ Time Frame: 6 month ]
  • Beck Depression Inventory [ Time Frame: 6 month ]
  • Buss & Perry Aggression Questionnaire [ Time Frame: 6 month ]


Original Secondary Outcome: Same as current

Information By: Beijing Pins Medical Co., Ltd

Dates:
Date Received: September 26, 2014
Date Started: December 2016
Date Completion: December 2018
Last Updated: October 13, 2016
Last Verified: August 2016