NCT01176721
Completed
Phase 2
Transcutaneous Non-invasive Vagus Nerve Stimulation (t-VNS) in the Treatment of Schizophrenia: a Randomized, Controlled, Double Blind, Two-armed Clinical Trial
cerbomed GmbH2 sites in 1 country20 target enrollmentMarch 2010
ConditionsSchizophrenia
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- cerbomed GmbH
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Safety and efficacy of t-VNS in schizophrenia
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Study hypothesis: t-VNS may improve negative symptoms, depressive symptoms, cognitive impairment,and aggressive behavior of treated schizophrenia patients.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Safety and efficacy of t-VNS in schizophrenia
Time Frame: 24 weeks
Secondary Outcomes
- Recording of clinical performance of t-VNS in schizophrenia(24 weeks)
Study Sites (2)
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