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

Schizophrenia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176721
• Other study ID #: 02VNS2009
• Status: Completed
• Phase: Phase 2
• First received: August 5, 2010
• Last updated: September 11, 2012
• Start date: March 2010
• Est. completion date: February 2012

Study information

• Verified date: September 2012
• Source: cerbomed GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Device:
• t-VNS verum
Active stimulation of the left auricle by t-VNS
• t-VNS placebo
Sham stimulation of the left auricle with the t-VNS device

Locations

Country	Name	City	State
Germany	Departement of Psychiatry and Psychotherapy, University Hospital of Goettingen	Goettingen	Niedersachsen
Germany	Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universitaet Muenchen	Munich	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
cerbomed GmbH	Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and efficacy of t-VNS in schizophrenia		24 weeks	Yes
Secondary	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	No