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

September 11, 2012 updated by: cerbomed GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 80336
        • Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universitaet Muenchen
    • Niedersachsen
      • Goettingen, Niedersachsen, Germany, 37075
        • Departement of Psychiatry and Psychotherapy, University Hospital of Goettingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and efficacy of t-VNS in schizophrenia
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

cerbomed GmbH

Collaborators

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

August 5, 2010

First Submitted That Met QC Criteria

August 5, 2010

First Posted (Estimate)

August 6, 2010

Study Record Updates

Last Update Posted (Estimate)

September 12, 2012

Last Update Submitted That Met QC Criteria

September 11, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02VNS2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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