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| ID | Type | Description | Link |
|---|---|---|---|
| 2U44DC010084-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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Assess the safety and efficacy of VNS paired with tones for tinnitus using a randomized, controlled, parallel study design.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VNS Treatment | Experimental | Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period. |
|
| VNS Control | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VNS Treatment | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6-weeks |
| Change in Minimum Masking Level (MML) in Units of dB (Decibels) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tinnitus Functional Index (TFI) | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| W Brent Tarver, BSEE | MicroTransponder Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U. Iowa | Iowa City | Iowa | 52242 | United States | ||
| U. Buffalo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23099209 | Background | 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. | |
| 21228773 | Background | 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. |
| Label | URL |
|---|---|
| Link to study website | View source |
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Individual participant data (IPD) is not planned to be shared.
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Sixty-two subjects were screened for inclusion into the study. Nine (9) did not meet inclusion criteria, 15 declined to participate, 3 had medical issues, and 5 were screened but were after the study limit of 30. Thirty subjects were enrolled and implanted with the study device.
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| ID | Title | Description |
|---|---|---|
| FG000 | VNS Treatment | Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period. 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients with tinnitus
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| ID | Title | Description |
|---|---|---|
| BG000 | VNS Treatment | Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period. 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 6-weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VNS Treatment | Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | Hoarseness due to damage to the vagus nerve; recovers over time. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coughing | Respiratory, thoracic and mediastinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical Affairs | MicroTransponder | 512-371-4160 | studies@microtransponder.com |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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|
| VNS Control | Device | 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. |
|
Asses the change in minimum masking level (MML) for both groups and compare between the groups. |
| 6-weeks (pre-implant to after 6-weeks of VNS) |
| 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. | 6-weeks (pre-implant to after 6-weeks of VNS) |
| 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. | 6-weeks (pre-implant to after 6-weeks of VNS) |
| 6-weeks (pre-implant to after 6-weeks of VNS) |
| Buffalo |
| New York |
| 14214 |
| United States |
| UT Dallas | Dallas | Texas | 75235 | United States |
| 28931943 | Background | 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. |
| 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | Posted | Number | participants | 6-weeks |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | dB (decibels) | 6-weeks (pre-implant to after 6-weeks of VNS) |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | percentage change of THI | 6-weeks (pre-implant to after 6-weeks of VNS) |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6-weeks (pre-implant to after 6-weeks of VNS) |
|
|
|
| Other Pre-specified | Change in Tinnitus Functional Index (TFI) | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6-weeks (pre-implant to after 6-weeks of VNS) |
|
|
|
| 1 |
| 16 |
| 2 |
| 16 |
| EG001 | 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. 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. | 2 | 14 | 1 | 14 |
|
| Surgery | Surgical and medical procedures | Surgery to replace broken lead |
|
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |