Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus

Not Applicable

Completed

Conditions: Tinnitus

Interventions: Device: VNS Treatment
Device: VNS Control

Registration Number: NCT01962558

Lead Sponsor: MicroTransponder Inc.

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

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

Inclusion Criteria

22 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

Exclusion Criteria

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VNS Treatment	VNS Treatment	Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.
VNS Control	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Serious Adverse Events	6-weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Tinnitus Handicap Questionnaire (THQ)	6-weeks (pre-implant to after 6-weeks of VNS)	Assess the change in THQ score for both groups and compare between the groups. The THQ is a patient questionnaire with 27 questions with each question having a score from 1 to 100. Scoring includes three factors - Factor 1 (Social, Emotional, Behavioral), Factor 2 (Tinnitus and Hearing), Factor 3 (Outlook). Fifteen questions are included in Factor 1, 8 questions in Factor 2, and 4 questions in Factor 3. A total score is calculated by adding the scores for Factor 1 questions and multiplying by 15/27, adding the scores for Factor 2 and multiplying by 8/27, and adding the scores for Factor 3 and multiplying by 4/27. This is then summed for the total score. Total score ranges from 0 to 100, with higher scores indicating more severe tinnitus.
Change in Minimum Masking Level (MML) in Units of dB (Decibels)	6-weeks (pre-implant to after 6-weeks of VNS)	Asses the change in minimum masking level (MML) for both groups and compare between the groups.
Number of Participants With Adverse Events	6-weeks	Assess the number of adverse events during the study, and compare between groups to indicate if there are more in the treatment group than the control group.
Percent Change in Tinnitus Handicap Inventory (THI)	6-weeks (pre-implant to after 6-weeks of VNS)	Assess the change in THI score for both groups and compare between the groups. The THI is a questionnaire that asks subjects to assess their perception of their tinnitus by rating each question as a Yes (4 points), No (0 points) or Sometimes (2 points). There are 25 questions, scores are summed, so the scale ranges from 0 to 100. Scores are graded as: Grade 1 - Slight (0-16) Only heard in a quiet environment; Grade 2 - Mild (18-36) Easily masked by environmental sounds and easily forgotten with activities.; Grade 3 - Moderate (38-56) Noticed in presence of background noise, although daily activities can still be performed.; Grade 4 - Severe (58-76) Almost always heard, leads to disturbed sleep patterns and can interfere with daily activities.; Grade 5 - Catastrophic (78-100) Always heard, disturbed sleep patterns, difficulty with any activities.