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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
t-VNS verum
t-VNS placebo
Sponsored by
cerbomed GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring 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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universitaet Muenchen
  • Departement of Psychiatry and Psychotherapy, University Hospital of Goettingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

t-VNS verum

Sham

Arm Description

Active stimulation of the left auricle by t-VNS

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

Outcomes

Primary Outcome Measures

Safety and efficacy of t-VNS in schizophrenia

Secondary Outcome Measures

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

Full Information

First Posted
August 5, 2010
Last Updated
September 11, 2012
Sponsor
cerbomed GmbH
Collaborators
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01176721
Brief Title
Transcutaneous Non-invasive Vagus Nerve Stimulation (t-VNS) in the Treatment of Schizophrenia
Acronym
02VNS2009
Official Title
Transcutaneous Non-invasive Vagus Nerve Stimulation (t-VNS) in the Treatment of Schizophrenia: a Randomized, Controlled, Double Blind, Two-armed Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
cerbomed GmbH
Collaborators
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
t-VNS verum
Arm Type
Active Comparator
Arm Description
Active stimulation of the left auricle by t-VNS
Arm Title
Sham
Arm Type
Placebo Comparator
Arm Description
Sham-simulation of the left auricle by the t-VNS device.
Intervention Type
Device
Intervention Name(s)
t-VNS verum
Intervention Description
Active stimulation of the left auricle by t-VNS
Intervention Type
Device
Intervention Name(s)
t-VNS placebo
Intervention Description
Sham stimulation of the left auricle with the t-VNS device
Primary Outcome Measure Information:
Title
Safety and efficacy of t-VNS in schizophrenia
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Recording of clinical performance of t-VNS in schizophrenia
Description
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
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universitaet Muenchen
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80336
Country
Germany
Facility Name
Departement of Psychiatry and Psychotherapy, University Hospital of Goettingen
City
Goettingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany

12. IPD Sharing Statement

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

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