Tinnitus
Conditions
Brief summary
Tinnitus is a persistent non-physiologic, non-psychiatric, ringing in the ear that affects up to 20% of the general US population. The purpose of this study is to assess the patient reported effectiveness of Xeomin (incobotulinumtoxinA) injections into the auricular muscles for relief of tinnitus with use of the Tinnitus Handicap Inventory questionnaire.
Interventions
The study intervention is a syringe of 50 units of incobotulinum toxin A total, with 25 units per side, a total of 6 injection sites incobotulinum toxin A diluted into 1 ml of normal saline, injected in equal amounts into the anterior, superior, and posterior auricular muscles using anatomical landmarks. This will be approximately 0.16 mL (8-9 units) of the combined solution per injection site.
DRUGPlacebo-Saline
Placebo injections will be preservative free normal saline. Injections will be administered similar to the drug injections.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults age 18 or older * Unilateral or bilateral tinnitus present for ≥ 2 months * A score \>16 on the Tinnitus Handicap Inventory * Participants must be willing and able to provide informed consent.
Exclusion criteria
* Patients with known hypersensitivity to any botulinum toxin product or to any of the components in the formulation. * Patients who have received botulinum toxin injections for any medical reason within 4 months prior to screening. * Patients with infection at proposed injection sites. * Patients scheduled for neurological or otological surgery for chronic ear disease, vestibular schwannoma, meningioma, or skull base tumors. * Significant psychiatric history or associated diagnosis of major depression. * Women who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Tinnitus Handicap Inventory score | pre-injection baseline to 4-6 weeks post injection | in the group assigned to placebo for the first stage |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStephanie Standal, MD
University of Minnesota
Outcome results
None listed