The Treatment of Tinnitus With Transcutaneous Non-invasive Vagus Nerve Stimulation

cerbomed

Status: Completed

Conditions: Tinnitus

Treatments: Device: tVNS-Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01176734

cMPsTIN01

Details and patient eligibility

About

The t-VNS STv3 device is a non-invasive, transcutaneous neurostimulator for influencing the afferent branches of the nervus vagus around the human ear. The clinical trial is designed as a a pilot study addressing the treatment of tinnitus with transcutaneous vagus nerve stimulation.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic tinnitus defined as a tinnitus over more than six months
• ≥31 points in the tinnitus questionnaire according to Goebel and Hiller
• Written informed consent
• Both gender, aged from 18 -75 years
• If the subject takes psychoactive medication (e.g antidepressants, anticonvulsives) therapy must be stable for at least 10 days. If a treatment with neuroleptics is necessary, only olanzapine and quetiapine should be used. The therapy should be constantly though a necessary change in medication is no reason for exclusion of the subject.

Exclusion criteria

• Objective tinnitus
• Participating in other tinnitus treatments within 3 months before study start
• Missing informed consent
• Pregnancy
• Bronchial asthma in medical history
• Clinically relevant internistic, neurological or psychiatric diseases
• Abuse of drugs or alcohol until 12 weeks before enrollment in the study
• Indications of structural impairment of the basal ganglia or the brain stem
• Active implants (e.g. cochlea implants, VNS, pacemaker)
• Constant all-day use of hearing instruments or noisers on the left the part-time use in special situations (e.g. watching TV is no exclusion criteria
• All dermatologic and infectious diseases which affect the area around the pinna and the ear canal
• Severe malformation of the pinna
• Other circumstances that in the opinion of the investigator might be an obstacle for enrolling the subject

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

active t-VNS

Experimental group

Description:

active t-VNS

Treatment:

Device: tVNS-Device