Schizophrenia Clinical Trial
— 02VNS2009Official title:
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | February 2012 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Departement of Psychiatry and Psychotherapy, University Hospital of Goettingen | Goettingen | Niedersachsen |
Germany | Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universitaet Muenchen | Munich | Bavaria |
Lead Sponsor | Collaborator |
---|---|
cerbomed GmbH | Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and efficacy of t-VNS in schizophrenia | 24 weeks | Yes | |
Secondary | Recording of clinical performance of t-VNS in schizophrenia | 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 |
24 weeks | No |
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