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Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus

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ClinicalTrials.gov Identifier: NCT01962558
Recruitment Status : Completed
First Posted : October 14, 2013
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
MicroTransponder Inc.

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

Condition or disease Intervention/treatment Phase
Tinnitus Device: VNS Treatment Device: VNS Control Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Blinded Randomized Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus vs. VNS With Unpaired Tones
Study Start Date : February 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: VNS Treatment
Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.
Device: 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.
Other Names:
  • VNS paired with tones
  • Serenity System
Sham Comparator: 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.
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.



Primary Outcome Measures :
  1. Number of Participants With Serious Adverse Events [ Time Frame: 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 :
  1. Number of Participants With Adverse Events [ Time Frame: 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.

  2. Change in Minimum Masking Level (MML) in Units of dB (Decibels) [ Time Frame: 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.

  3. Percent Change in Tinnitus Handicap Inventory (THI) [ Time Frame: 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.

  4. Change in Tinnitus Handicap Questionnaire (THQ) [ Time Frame: 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.


Other Outcome Measures:
  1. Change in Tinnitus Functional Index (TFI) [ Time Frame: 6-weeks (pre-implant to after 6-weeks of VNS) ]
    Assess the change in TFI score for both groups and compare between the groups. The TFI has eight subscales that address the intrusiveness of tinnitus, the sense of control the patient has, cognitive interference, sleep disturbance, auditory issues, relaxation issues, quality of life, and emotional distress. There are a total of 25 questions, with a range of 0 to 10 on each item (0 to 250) total. All valid answers are summed, divided by the number of questions which were answered, and multiplied by 10 (0-100 range). Score range from 0 to 100 with higher scores indicating worse tinnitus.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   22 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01962558


Locations
United States, Iowa
U. Iowa
Iowa City, Iowa, United States, 52242
United States, New York
U. Buffalo
Buffalo, New York, United States, 14214
United States, Texas
UT Dallas
Dallas, Texas, United States, 75235
Sponsors and Collaborators
MicroTransponder Inc.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Study Director: W Brent Tarver, BSEE MicroTransponder Inc.

Additional Information:
Publications:
Responsible Party: MicroTransponder Inc.
ClinicalTrials.gov Identifier: NCT01962558     History of Changes
Other Study ID Numbers: MT-T-02
2U44DC010084-04 ( U.S. NIH Grant/Contract )
First Posted: October 14, 2013    Key Record Dates
Results First Posted: April 6, 2018
Last Update Posted: April 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data (IPD) is not planned to be shared.

Keywords provided by MicroTransponder Inc.:
Tinnitus
Medical Device
Randomized
Vagus Nerve Stimulation

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms