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Transcutaneous Non-invasive Vagus Nerve Stimulation (t-VNS) in the Treatment of Schizophrenia (02VNS2009)

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ClinicalTrials.gov Identifier: NCT01176721
Recruitment Status : Completed
First Posted : August 6, 2010
Last Update Posted : September 12, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Device: t-VNS verum Device: t-VNS placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcutaneous Non-invasive Vagus Nerve Stimulation (t-VNS) in the Treatment of Schizophrenia: a Randomized, Controlled, Double Blind, Two-armed Clinical Trial
Study Start Date : March 2010
Primary Completion Date : July 2011
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: t-VNS verum
Active stimulation of the left auricle by t-VNS
Device: t-VNS verum
Active stimulation of the left auricle by t-VNS
Placebo Comparator: Sham
Sham-simulation of the left auricle by the t-VNS device.
Device: t-VNS placebo
Sham stimulation of the left auricle with the t-VNS device

Outcome Measures

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

Secondary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01176721

Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universitaet Muenchen
Munich, Bavaria, Germany, 80336
Departement of Psychiatry and Psychotherapy, University Hospital of Goettingen
Goettingen, Niedersachsen, Germany, 37075
Sponsors and Collaborators
cerbomed GmbH
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
More Information

Responsible Party: cerbomed GmbH
ClinicalTrials.gov Identifier: NCT01176721     History of Changes
Other Study ID Numbers: 02VNS2009
First Posted: August 6, 2010    Key Record Dates
Last Update Posted: September 12, 2012
Last Verified: September 2012

Keywords provided by cerbomed GmbH:
neuroleptic malignant syndrome
atypical antipsychotics
schizophrenic disorders
residual-type schizophrenia
split mind
mental health disorder
paranoid-type schizophrenia
disorganized-type schizophrenia
undifferentiated-type schizophrenia
catatonic-type schizophrenia
mental illness
tardive dyskinesia
psychosocial treatments

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders