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

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Device: t-VNS verum; Device: t-VNS placebo

• Registration Number: NCT01176721
• Lead Sponsor: cerbomed GmbH

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 Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-08-05
• Study First Submitted QC: 2010-08-05
• Study First Posted: 2010-08-06
• Primary Completion: 2011-07
• Study Completion: 2012-02
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-11
• Last Update Posted: 2012-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Diagnosis of a schizophrenic disorder (F20 according to ICD-10),duration of disease ≥ 12 months
• Appliance of the t-VNS® medical device according to the manual

Exclusion Criteria

• Improvent of the PANSS score within the period of 2 - 4 weeks from screening to the baseline
• Pregnancy
• Bronchial asthhma in medical history
• clinically relevant internistic, neurological or psychiatric diseases
• abuse of drugs or alcohol until 4 weeks to enrollment
• Traumatic brain injury in medical history as well as invasive and non-invasive methods of treatment (e.g. tumor surgery (Gammma knife surgery))
• indication of structural impairment of the basal ganglia or the brain stem
• malformations of the pinna
• further circumstances that at the discretion of the investigator will not allow to include the subject into the clinical study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
t-VNS verum	t-VNS verum	Active stimulation of the left auricle by t-VNS
Sham	t-VNS placebo	Sham-simulation of the left auricle by the t-VNS device.

Primary Outcome Measures

Name	Time	Method
Safety and efficacy of t-VNS in schizophrenia	24 weeks

Secondary Outcome Measures

Name	Time	Method
Recording of clinical performance of t-VNS in schizophrenia	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

Trial Locations

Locations (2)

Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universitaet Muenchen; 🇩🇪 Munich, Bavaria, Germany

Departement of Psychiatry and Psychotherapy, University Hospital of Goettingen; 🇩🇪 Goettingen, Niedersachsen, Germany