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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.

Tracking Information
First Submitted Date  ICMJE October 9, 2013
First Posted Date  ICMJE October 14, 2013
Results First Submitted Date  ICMJE August 28, 2017
Results First Posted Date  ICMJE April 6, 2018
Last Update Posted Date April 6, 2018
Study Start Date  ICMJE February 2014
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 10, 2013)
Number of 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.
Change History Complete list of historical versions of study NCT01962558 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2013)
  • Number of 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.
  • Minimum masking level (MML) in units of dB (decibels) [ Time Frame: 6-weeks ]
    Asses the change in minimm masking level (MML) for both groups and compare between the groups.
  • Tinnitus Handicap Inventory (THI) [ Time Frame: 6-weeks ]
    Assess the change in THI score for both groups and compare between the groups.
  • Tinnitus Handicap Questionnaire (THQ) [ Time Frame: 6-weeks ]
    Assess the change in THQ score for both groups and compare between the groups.
Current Other Pre-specified Outcome Measures
 (submitted: March 9, 2018)
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.
Original Other Pre-specified Outcome Measures
 (submitted: October 10, 2013)
  • Beck Depression Inventory (BDI) [ Time Frame: 6-weeks ]
    Assess the change in BDI score for both groups and compare between the groups.
  • State-Trait Anxiety Inventory (STAI) [ Time Frame: 6-weeks ]
    Assess the change in STAI score for both groups and compare between the groups.
  • Tinnitus Functional Index (TFI) [ Time Frame: 6-weeks ]
    Assess the change in TFI score for both groups and compare between the groups.
 
Descriptive Information
Brief Title  ICMJE Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus
Official Title  ICMJE A Blinded Randomized Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus vs. VNS With Unpaired Tones
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tinnitus
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: VNS Treatment
    Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period.
    Intervention: Device: VNS Treatment
  • 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.
    Intervention: Device: VNS Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2013)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01962558
Other Study ID Numbers  ICMJE MT-T-02
2U44DC010084-04 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual participant data (IPD) is not planned to be shared.
Responsible Party MicroTransponder Inc.
Study Sponsor  ICMJE MicroTransponder Inc.
Collaborators  ICMJE National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators  ICMJE
Study Director: W Brent Tarver, BSEE MicroTransponder Inc.
PRS Account MicroTransponder Inc.
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP