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Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VNS Treatment
VNS Control
Sponsored by
MicroTransponder Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus, Medical Device, Randomized, Vagus Nerve Stimulation

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • U. Iowa
  • U. Buffalo
  • UT Dallas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

VNS Treatment

VNS Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
October 9, 2013
Last Updated
March 9, 2018
Sponsor
MicroTransponder Inc.
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT01962558
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MicroTransponder Inc.
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Tinnitus, Medical Device, Randomized, Vagus Nerve Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VNS Treatment
Arm Type
Experimental
Arm Description
Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.
Arm Title
VNS Control
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
VNS Treatment
Other Intervention Name(s)
VNS paired with tones, Serenity System
Intervention Description
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
Intervention Name(s)
VNS Control
Intervention Description
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 Measure Information:
Title
Number of Participants With Serious Adverse Events
Description
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.
Time Frame
6-weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
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.
Time Frame
6-weeks
Title
Change in Minimum Masking Level (MML) in Units of dB (Decibels)
Description
Asses the change in minimum masking level (MML) for both groups and compare between the groups.
Time Frame
6-weeks (pre-implant to after 6-weeks of VNS)
Title
Percent Change in Tinnitus Handicap Inventory (THI)
Description
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.
Time Frame
6-weeks (pre-implant to after 6-weeks of VNS)
Title
Change in Tinnitus Handicap Questionnaire (THQ)
Description
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.
Time Frame
6-weeks (pre-implant to after 6-weeks of VNS)
Other Pre-specified Outcome Measures:
Title
Change in Tinnitus Functional Index (TFI)
Description
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.
Time Frame
6-weeks (pre-implant to after 6-weeks of VNS)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
W Brent Tarver, BSEE
Organizational Affiliation
MicroTransponder Inc.
Official's Role
Study Director
Facility Information:
Facility Name
U. Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
U. Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
Facility Name
UT Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) is not planned to be shared.
Citations:
PubMed Identifier
23099209
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.
Results Reference
background
PubMed Identifier
21228773
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.
Results Reference
background
PubMed Identifier
28931943
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.
Results Reference
background
Links:
URL
http://www.tinnitustrial.com
Description
Link to study website

Learn more about this trial

Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus

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