Status:
COMPLETED
Transcutaneous Non-invasive Vagus Nerve Stimulation (t-VNS) in the Treatment of Schizophrenia
Lead Sponsor:
cerbomed GmbH
Collaborating Sponsors:
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Conditions:
Schizophrenia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01176721
Start Date
March 1 2010
End Date
February 1 2012
Last Update
September 12 2012
Active Locations (2)
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1
Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universitaet Muenchen
Munich, Bavaria, Germany, 80336
2
Departement of Psychiatry and Psychotherapy, University Hospital of Goettingen
Göttingen, Lower Saxony, Germany, 37075