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

NCT ID: NCT01176721

Last Updated: 2012-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-02-29

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.

Detailed Description

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Conditions

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Schizophrenia

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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t-VNS verum

Active stimulation of the left auricle by t-VNS

Group Type ACTIVE_COMPARATOR

t-VNS verum

Intervention Type DEVICE

Active stimulation of the left auricle by t-VNS

Sham

Sham-simulation of the left auricle by the t-VNS device.

Group Type PLACEBO_COMPARATOR

t-VNS placebo

Intervention Type DEVICE

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

Interventions

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t-VNS verum

Active stimulation of the left auricle by t-VNS

Intervention Type DEVICE

t-VNS placebo

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

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

OTHER

Sponsor Role collaborator

cerbomed GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universitaet Muenchen

Munich, Bavaria, Germany

Site Status

Departement of Psychiatry and Psychotherapy, University Hospital of Goettingen

Göttingen, Lower Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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02VNS2009

Identifier Type: -

Identifier Source: org_study_id