Proof-of-Concept Study Assessing VNS Paired With Tones for Tinnitus

Severe Tinnitus Clinical Trial

Official title:

A Proof-of-Concept Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01253616
• Other study ID #: MT-T-01
• Status: Completed
• Phase: N/A
• First received: December 2, 2010
• Last updated: February 16, 2017
• Start date: December 2010
• Est. completion date: June 2012

Study information

• Verified date: February 2017
• Source: MicroTransponder Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a proof-of-concept study designed to provide feasibility information on the clinical use of vagus nerve stimulation (VNS) paired with tones for the treatment of severe tinnitus. The study is expected to give preliminary efficacy and safety information.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Key Inclusion Criteria:

• 18 to 65 years of age

• Diagnosed with subjective tinnitus due to hearing loss with at least some tonal quality of the tinnitus.

• Diagnosis of tinnitus for at least one year

• Tinnitus severity of 18 or greater on TRQ cross checked with TQ severity of Grade 3 or worse

Key Exclusion Criteria:

• Acute or intermittent tinnitus

• Severe hearing loss

• History of significant ear disease such as Meniere's disease, ear tumors, or evidence of active middle ear disease.

• Any other implanted device

Related Conditions & MeSH terms

• Severe Tinnitus
• Tinnitus

Intervention

Device:
• vagus nerve stimulation (VNS)
Daily stimulation synchronized with tones at the study assigned dose (amplitude, frequency, on/off cycle and treatment period).

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Antwerp	Edegem

Sponsors (1)

Lead Sponsor	Collaborator
MicroTransponder Inc.

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

De Ridder D, Kilgard M, Engineer N, Vanneste S. Placebo-controlled vagus nerve stimulation paired with tones in a patient with refractory tinnitus: a case report. Otol Neurotol. 2015 Apr;36(4):575-80. doi: 10.1097/MAO.0000000000000704. — View Citation

De Ridder D, Vanneste S, Engineer ND, Kilgard MP. Safety and efficacy of vagus nerve stimulation paired with tones for the treatment of tinnitus: a case series. Neuromodulation. 2014 Feb;17(2):170-9. doi: 10.1111/ner.12127. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Audiometric measurements		weekly through one month
Secondary	tinnitus questionaires		weekly through one month
Secondary	adverse events		as they occur