NCT01176721

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: cerbomed GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DEVICE	t-VNS verum	Active stimulation of the left auricle by t-VNS
DEVICE	t-VNS placebo	Sham stimulation of the left auricle with the t-VNS device

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-07-01
• Completion: 2012-02-01
• First posted: 2010-08-06
• Last updated: 2012-09-12

Locations

2 sites across 1 country: Germany