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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01176721

Acronym

02VNS2009

Enrollment

Registered

2010-08-06

Start date

2010-03-31

Completion date

2012-02-29

Last updated

2012-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

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

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.

Interventions

DEVICEt-VNS verum

Active stimulation of the left auricle by t-VNS

DEVICEt-VNS placebo

Sham stimulation of the left auricle with the t-VNS device

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Safety and efficacy of t-VNS in schizophrenia	24 weeks

Secondary

Measure	Time frame	Description
Recording of clinical performance of t-VNS in schizophrenia	24 weeks	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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026