Transcutaneous Non-invasive Vagus Nerve Stimulation (t-VNS) in the Treatment of Schizophrenia (02VNS2009)

cerbomed

Status and phase

Completed

Phase 2

Conditions

Schizophrenia

Treatments

Device: t-VNS placebo

Device: t-VNS verum

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01176721

02VNS2009

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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