Trial record 1 of 3 for:    tinnitus vns
Previous Study | Return to List | Next Study

Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by MicroTransponder Inc.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
MicroTransponder Inc.
ClinicalTrials.gov Identifier:
NCT01962558
First received: October 9, 2013
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention
Tinnitus
Device: VNS Treatment
Device: VNS Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by MicroTransponder Inc.:

Primary Outcome Measures:
  • Number of Serious Adverse Events [ Time Frame: 6-weeks ] [ Designated as safety issue: Yes ]
    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 Adverse Events [ Time Frame: 6-weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Asses the change in minimum masking level (MML) for both groups and compare between the groups.

  • Tinnitus Handicap Inventory (THI) [ Time Frame: 6-weeks ] [ Designated as safety issue: No ]
    Assess the change in THI score for both groups and compare between the groups.

  • Tinnitus Handicap Questionnaire (THQ) [ Time Frame: 6-weeks ] [ Designated as safety issue: No ]
    Assess the change in THQ score for both groups and compare between the groups.


Other Outcome Measures:
  • Beck Depression Inventory (BDI) [ Time Frame: 6-weeks ] [ Designated as safety issue: Yes ]
    Assess the change in BDI score for both groups and compare between the groups.

  • State-Trait Anxiety Inventory (STAI) [ Time Frame: 6-weeks ] [ Designated as safety issue: Yes ]
    Assess the change in STAI score for both groups and compare between the groups.

  • Tinnitus Functional Index (TFI) [ Time Frame: 6-weeks ] [ Designated as safety issue: No ]
    Assess the change in TFI score for both groups and compare between the groups.


Estimated Enrollment: 30
Study Start Date: February 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   22 Years to 65 Years
Genders Eligible for Study:   Both
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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01962558

Contacts
Contact: W Brent Tarver studies@microtransponder.com

Locations
United States, Iowa
U. Iowa Recruiting
Iowa City, Iowa, United States, 52242
United States, New York
U. Buffalo Recruiting
Buffalo, New York, United States, 14214
United States, Texas
UT Dallas Recruiting
Dallas, Texas, United States, 75235
Sponsors and Collaborators
MicroTransponder Inc.
Investigators
Study Director: W Brent Tarver, BSEE MicroTransponder Inc.
  More Information

Additional Information:
Publications:
Responsible Party: MicroTransponder Inc.
ClinicalTrials.gov Identifier: NCT01962558     History of Changes
Other Study ID Numbers: MT-T-02, 2U44DC010084-04
Study First Received: October 9, 2013
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 19, 2014