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Completed

NCT Number: NCT01176721

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

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.

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Key information

Conditions

Schizophrenia Basal Ganglia Diseases Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Chemically-Induced Disorders Delusions Dementia Dyskinesia, Drug-Induced Dyskinesias Hallucinations Illusions Mental Disorders Movement Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neuroleptic Malignant Syndrome Neurologic Manifestations Neurotoxicity Syndromes Pathological Conditions, Signs and Symptoms Perceptual Disorders Poisoning Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Schizophrenia, Catatonic Schizophrenia, Disorganized Schizophrenia, Paranoid Signs and Symptoms Tardive Dyskinesia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universitaet Muenchen, Munich, Bavaria, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

t-VNS verum

Device

Active stimulation of the left auricle by t-VNS

t-VNS placebo

Device

Sham stimulation of the left auricle with the t-VNS device

Primary outcomes

  1. Safety and efficacy of t-VNS in schizophrenia

    Time frame: 24 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

cerbomed GmbH

Industry

Collaborators

  • Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Registry information

Official study title

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

Acronym: 02VNS2009

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Aug 6, 2010
Registry last updated
Sep 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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