Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus
|ClinicalTrials.gov Identifier: NCT01962558|
Recruitment Status : Completed
First Posted : October 14, 2013
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus||Device: VNS Treatment Device: VNS Control||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
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.
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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01962558
|United States, Iowa|
|Iowa City, Iowa, United States, 52242|
|United States, New York|
|Buffalo, New York, United States, 14214|
|United States, Texas|
|Dallas, Texas, United States, 75235|
|Study Director:||W Brent Tarver, BSEE||MicroTransponder Inc.|