Clinical Trial: Transcutaneous Non-invasive Vagus Nerve Stimulation (t-VNS) in the Treatment of Schizophrenia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Transcutaneous Non-invasive Vagus Nerve Stimulation (t-VNS) in the Treatment of Schizophrenia: a Randomized, Controlled, Double Blind, Two-armed Clinical Trial

Brief Summary:

Randomized, controlled, double-blind, two-armed clinical investigation to show the efficacy and safety of transcutaneous vagus nerve stimulation (t-VNS), applied at the left auricle, in schizophrenia.

Study hypothesis: t-VNS may improve negative symptoms, depressive symptoms, cognitive impairment,and aggressive behavior of treated schizophrenia patients.


Detailed Summary:
Sponsor: cerbomed GmbH

Current Primary Outcome: Safety and efficacy of t-VNS in schizophrenia [ Time Frame: 24 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Recording of clinical performance of t-VNS in schizophrenia [ Time Frame: 24 weeks ]

self rating:

  • BDI
  • Fagerström

rating by investigator

  • UKU
  • SANS
  • CDSS
  • MARDS
  • HAMD-21
  • CGI
  • PSP
  • SWN_K
  • St. Hans
  • VLMT
  • TMT-B
  • TMT-A
  • RWT
  • Corsi Block Tapping
  • Zahlennachsprechen
  • MWT-B
  • EKT
  • HR
  • dTMS


Original Secondary Outcome: Same as current

Information By: cerbomed GmbH

Dates:
Date Received: August 5, 2010
Date Started: March 2010
Date Completion:
Last Updated: September 11, 2012
Last Verified: September 2012