Clinical trial NCT01962558: Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus
Official title: A Blinded Randomized Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus vs. VNS With Unpaired Tones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: Tinnitus
Medical Device
Randomized
Vagus Nerve Stimulation
Lead sponsor: MicroTransponder Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2013-10-14
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of Participants With Serious Adverse Events
timeFrame: 6-weeks
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 6-weeks
measure: Change in Minimum Masking Level (MML) in Units of dB (Decibels)
timeFrame: 6-weeks (pre-implant to after 6-weeks of VNS)
measure: Percent Change in Tinnitus Handicap Inventory (THI)
timeFrame: 6-weeks (pre-implant to after 6-weeks of VNS)
measure: Change in Tinnitus Handicap Questionnaire (THQ)
timeFrame: 6-weeks (pre-implant to after 6-weeks of VNS)
Other outcomes:
measure: Change in Tinnitus Functional Index (TFI)
timeFrame: 6-weeks (pre-implant to after 6-weeks of VNS)
Locations:
city: Iowa City
country: United States
facility: U. Iowa
state: Iowa
city: Buffalo
country: United States
facility: U. Buffalo
state: New York
city: Dallas
country: United States
facility: UT Dallas
state: Texas
Study officials:
affiliation: MicroTransponder Inc.
name: W Brent Tarver, BSEE
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.