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

Study Overview
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Brief Summary
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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.

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Device: t-VNS verum
* Device: t-VNS placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: t-VNS verum<br>Active stimulation of the left auricle by t-VNS | Device: t-VNS verum<br>* Active stimulation of the left auricle by t-VNS<br>|
| Placebo Comparator: Sham<br>Sham-simulation of the left auricle by the t-VNS device. | Device: t-VNS placebo<br>* Sham stimulation of the left auricle with the t-VNS device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy of t-VNS in schizophrenia |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenic disorders, psychosis, psychotic, dementia, delusional, delusions, hallucinations, residual-type schizophrenia, illusions, split mind, mental health disorder, schizoid, paranoid-type schizophrenia, disorganized-type schizophrenia, undifferentiated-type schizophrenia, catatonic-type schizophrenia, mental illness, tardive dyskinesia, neuroleptic malignant syndrome, NMS, antipsychotics, atypical antipsychotics, psychosocial treatments, rehabilitation