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

This study has been completed.

Sponsor:

Collaborator:

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Information provided by (Responsible Party):

cerbomed GmbH

ClinicalTrials.gov Identifier:

NCT01176721

First received: August 5, 2010

Last updated: September 11, 2012

Last verified: September 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	August 5, 2010
Last Updated Date	September 11, 2012
Start Date ^ICMJE	March 2010
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 5, 2010)	Safety and efficacy of t-VNS in schizophrenia [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01176721 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 5, 2010)	Recording of clinical performance of t-VNS in schizophrenia [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] 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 Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Transcutaneous Non-invasive Vagus Nerve Stimulation (t-VNS) in the Treatment of Schizophrenia
Official Title ^ICMJE	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 Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Schizophrenia
Intervention ^ICMJE	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
Study Arm (s)	Active Comparator: t-VNS verum Active stimulation of the left auricle by t-VNS Intervention: Device: t-VNS verum Placebo Comparator: Sham Sham-simulation of the left auricle by the t-VNS device. Intervention: Device: t-VNS placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20
Completion Date	February 2012
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01176721
Other Study ID Numbers ^ICMJE	02VNS2009
Has Data Monitoring Committee	Yes
Responsible Party	cerbomed GmbH
Study Sponsor ^ICMJE	cerbomed GmbH
Collaborators ^ICMJE	Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Investigators ^ICMJE	Not Provided
Information Provided By	cerbomed GmbH
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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