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