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

August 5, 2010
September 11, 2012
March 2010
July 2011   (final data collection date for primary outcome measure)
Safety and efficacy of t-VNS in schizophrenia [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01176721 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2012
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01176721
02VNS2009
Yes
cerbomed GmbH
cerbomed GmbH
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Not Provided
cerbomed GmbH
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP