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TinnitusNCT01962558

Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus

A study testing VNS Treatment in people with Tinnitus, run by MicroTransponder Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 22 to 65 years
Conditions the study is for
Tinnitus
What is being tested?
VNS Treatment
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
3 sitesUnited States
Study dates
Feb 2014to May 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • U. Buffalo

    Buffalo, New York, 14214

  • UT Dallas

    Dallas, Texas, 75235

  • U. Iowa

    Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: A Blinded Randomized Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus vs. VNS With Unpaired Tones

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

Read the 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.

Conditions
Tinnitus
Being tested
VNS Treatment, VNS Control
Keywords
Tinnitus, Medical Device, Randomized, Vagus Nerve Stimulation
Medical subject headings
Tinnitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VNS TreatmentDevice

    Also called VNS paired with tones, Serenity System

    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 ControlDevice

    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.

Study groups in NCT01962558
Study groupRoleWhat they receive
VNS TreatmentExperimentalVagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.
Receives: Device: VNS Treatment
VNS ControlSham comparatorVagus 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.
Receives: Device: VNS Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6-weeks

Secondary outcomes (4)

  1. Number of Participants With Adverse Events

    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.

    Measured: 6-weeks

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

    Asses the change in minimum masking level (MML) for both groups and compare between the groups.

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

  3. Percent Change in Tinnitus Handicap Inventory (THI)

    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.

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

  4. Change in Tinnitus Handicap Questionnaire (THQ)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2013 (estimated)
  2. Study startFeb 2014
  3. Primary completionMay 2015
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01962558
Sponsor's protocol ID
MT-T-02
Other IDs
2U44DC010084-04
Status last verified
Mar 2018
First submitted
9 Oct 2013
Last updated
6 Apr 2018
Data monitoring committee
Yes
Individual data sharing
No: Individual participant data (IPD) is not planned to be shared.

Publications

  • 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.

    PubMed 23099209

  • 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.

    PubMed 21228773

  • 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.

    PubMed 28931943

Questions about this trial

What is this clinical trial studying?

A study testing VNS Treatment in people with Tinnitus, run by MicroTransponder Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Serious Adverse Events (time frame: 6-weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01962558, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.

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