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
  Purpose

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 Intervention Phase
Schizophrenia
Device: t-VNS verum
Device: t-VNS placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by cerbomed GmbH:

Primary Outcome Measures:
  • Safety and efficacy of t-VNS in schizophrenia [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: March 2010
Study Completion Date: February 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176721

Locations
Germany
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

No publications provided

Responsible Party: cerbomed GmbH
ClinicalTrials.gov Identifier: NCT01176721     History of Changes
Other Study ID Numbers: 02VNS2009
Study First Received: August 5, 2010
Last Updated: September 11, 2012
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by cerbomed GmbH:
neuroleptic malignant syndrome
NMS
antipsychotics
atypical antipsychotics
schizophrenic disorders
psychosis
psychotic
dementia
delusional
delusions
hallucinations
residual-type schizophrenia
illusions
split mind
mental health disorder
schizoid
paranoid-type schizophrenia
disorganized-type schizophrenia
undifferentiated-type schizophrenia
catatonic-type schizophrenia
mental illness
tardive dyskinesia
psychosocial treatments
rehabilitation

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014