Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus

NCT01962558 | Completed Results DMC

• 2 other identifiers: MT-T-022U44DC010084-04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

Assess the safety and efficacy of VNS paired with tones for tinnitus using a randomized, controlled, parallel study design.

Conditions

Tinnitus

Keywords

Tinnitus; Medical Device; Randomized; Vagus Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Serious Adverse Events

  Assess the number of serious adverse events during the study, and compare between groups to indicate if there are more in the treatment group than the control group.

  6-weeks

Secondary Outcomes (4)

• Number of Participants With Adverse Events

  6-weeks

• Change in Minimum Masking Level (MML) in Units of dB (Decibels)

  6-weeks (pre-implant to after 6-weeks of VNS)

• Percent Change in Tinnitus Handicap Inventory (THI)

  6-weeks (pre-implant to after 6-weeks of VNS)

• Change in Tinnitus Handicap Questionnaire (THQ)

  6-weeks (pre-implant to after 6-weeks of VNS)

Other Outcomes (1)

• Change in Tinnitus Functional Index (TFI)

  6-weeks (pre-implant to after 6-weeks of VNS)

Study Arms (2)

VNS Treatment

EXPERIMENTAL

Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.

Device: VNS Treatment

VNS Control

SHAM COMPARATOR

Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained.

Device: VNS Control

Interventions

VNS Treatment DEVICE

VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS.

Also known as: VNS paired with tones, Serenity System

VNS Treatment

VNS Control DEVICE

This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective.

VNS Control

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years of age
• Have been diagnosed as suffering from sensorineural tinnitus and at least some tonal quality of the tinnitus
• Unilateral or bilateral tinnitus
• Have experienced tinnitus for at least one year and failed at least one tinnitus therapy (such as a counseling or sound therapy procedure. The diagnosis of tinnitus will include an audiological or medical diagnosis in their health records, as well as a patient affirmation of tinnitus greater than 12 months
• MML \>= 7 dB (decibel)
• Have tinnitus score of 40 or greater on the Tinnitus Handicap Questionnaire; (THQ)
• No tinnitus treatment for at least 4 weeks prior to study entry.
• Willing and able to understand and comply with all study-related procedures during the course of the study

You may not qualify if:

• Acute or intermittent tinnitus
• Severe hearing loss in any ear, as defined as more than an 80 dB HL (decibels hearing level) at frequencies from 250 Hz. to 8,000 Hz.
• Meniere's disease, ear tumors, or evidence of active middle ear disease (such as fluid, infection, tumor, mass)
• Any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug
• Pregnant or plan on becoming pregnant or breastfeeding during the study period
• Currently require, or likely to require, MRI or diathermy during the study duration
• History of adverse reactions to anesthetics (e.g., lidocaine) that in the Investigator's opinion make surgery too risky
• Beck Depression Inventory (BDI) of 30 or greater
• Any other form of tinnitus treatments (e.g. Herbal medication, acupuncture or chiropractic medicine) are not allowed during the study.
• Any drug known to mimic, increase or decrease release or removal of a diffuse neuromodulator, such as norepinephrine, dopamine, serotonin, benzodiazepines, and acetylcholine is not allowed, as well as any psychoactive medications.
• Significant cardiac history
• Use of any medication known to cause or increase tinnitus, such as NSAIDS (ibuprofen, naproxen, nabumetone, etc.), aspirin and other salicylates, furosemide (Lasix) and other "loop" diuretics, "mycin" antibiotics such as vancomycin, quinine and related drugs, and chemotherapy agents such as cisplatin.
• Involvement in litigation (e.g., worker's compensation claim and/or receiving disability benefits related to tinnitus and/or hearing loss).

Sponsors & Collaborators

• MicroTransponder Inc.: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (3)

U. Iowa

Iowa City, Iowa, 52242, United States

Location

U. Buffalo

Buffalo, New York, 14214, United States

Location

UT Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (3)

• Engineer ND, Moller AR, Kilgard MP. Directing neural plasticity to understand and treat tinnitus. Hear Res. 2013 Jan;295:58-66. doi: 10.1016/j.heares.2012.10.001. Epub 2012 Oct 23.

  PMID: 23099209 BACKGROUND

• Engineer ND, Riley JR, Seale JD, Vrana WA, Shetake JA, Sudanagunta SP, Borland MS, Kilgard MP. Reversing pathological neural activity using targeted plasticity. Nature. 2011 Feb 3;470(7332):101-4. doi: 10.1038/nature09656. Epub 2011 Jan 12.

  PMID: 21228773 BACKGROUND

• Tyler R, Cacace A, Stocking C, Tarver B, Engineer N, Martin J, Deshpande A, Stecker N, Pereira M, Kilgard M, Burress C, Pierce D, Rennaker R, Vanneste S. Vagus Nerve Stimulation Paired with Tones for the Treatment of Tinnitus: A Prospective Randomized Double-blind Controlled Pilot Study in Humans. Sci Rep. 2017 Sep 20;7(1):11960. doi: 10.1038/s41598-017-12178-w.

  PMID: 28931943 BACKGROUND

Related Links

• Link to study website

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: VP Clinical Affairs
• Organization: MicroTransponder

studies@microtransponder.com

512-371-4160

Study Officials

• W Brent Tarver, BSEE

  MicroTransponder Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 14, 2013
• Study Start: February 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2016
• Last Updated: April 6, 2018
• Results First Posted: April 6, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)