Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-05-31

Brief Summary

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

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Detailed Description

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Patients who have moderate to severe tinnitus, at least one year post diagnosis, may enroll. All patients will be implanted and randomized to one of two groups:

* a group receiving VNS paired with tones and;
* a group that receives VNS and tones, but with different settings.

After device use training, therapy is delivered at home by the patient for 6 weeks. Patients have eight baseline audiometric assessments along with two questionnaire assessments, an assessment after recovery before treatment starts, and tinnitus assessments every two weeks during therapy through the 6 week randomized portion of the study. After the randomized portion, all patients receive VNS paired with tones. Patients will continue to return for quarterly visits and tinnitus assessments through the first year after implant, regardless of their therapy status. Interested patients can continue to receive longer-term treatment after the first year. A goal of up to 30 patients enrolled and implanted across four sites is planned for this study.

Conditions

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Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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VNS Treatment

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

Group Type EXPERIMENTAL

VNS Treatment

Intervention Type 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.

VNS Control

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.

Group Type SHAM_COMPARATOR

VNS Control

Intervention Type 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.

Interventions

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VNS Treatment

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.

Intervention Type DEVICE

VNS Control

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.

Intervention Type DEVICE

Other Intervention Names

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VNS paired with tones Serenity System

Eligibility Criteria

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Inclusion Criteria

1. 22 to 65 years of age
2. Have been diagnosed as suffering from sensorineural tinnitus and at least some tonal quality of the tinnitus
3. Unilateral or bilateral tinnitus
4. 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
5. MML \>= 7 dB (decibel)
6. Have tinnitus score of 40 or greater on the Tinnitus Handicap Questionnaire; (THQ)
7. No tinnitus treatment for at least 4 weeks prior to study entry.
8. Willing and able to understand and comply with all study-related procedures during the course of the study

Exclusion Criteria

1. Acute or intermittent tinnitus
2. 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.
3. Meniere's disease, ear tumors, or evidence of active middle ear disease (such as fluid, infection, tumor, mass)
4. Any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug
5. Pregnant or plan on becoming pregnant or breastfeeding during the study period
6. Currently require, or likely to require, MRI or diathermy during the study duration
7. History of adverse reactions to anesthetics (e.g., lidocaine) that in the Investigator's opinion make surgery too risky
8. Beck Depression Inventory (BDI) of 30 or greater
9. Any other form of tinnitus treatments (e.g. Herbal medication, acupuncture or chiropractic medicine) are not allowed during the study.
10. 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.
11. Significant cardiac history
12. 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.
13. Involvement in litigation (e.g., worker's compensation claim and/or receiving disability benefits related to tinnitus and/or hearing loss).

Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No