An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus
D. Bradley Welling, MD, PhD
Summary
This is an exploratory pilot open-label study to identify the signal changes on fMRI of patients with tinnitus and with temporary suppression of the tinnitus with IV lidocaine. Patients will include those with hearing loss (both unilateral and bilateral) and tinnitus, subjects with normal hearing and tinnitus, and control subjects with normal hearing and no tinnitus. Eligible subjects will have functional and subjective data collected at baseline, receive an IV lidocaine infusion, and have functional and subjective data collected post-infusion for comparison and identification of involved neural networks.
Description
A total of 40 subjects will be enrolled in this study. Ten study volunteers will be enrolled in each of the following four groups: 1. \- Normal hearing (NH) without tinnitus (T-) 2. \- Normal hearing (NH) with tinnitus (T+) 3. \- Unilateral hearing loss (uHL) and ipsilateral unilateral tinnitus (uT+) 4. \- Bilateral hearing loss (bHL) and bilateral tinnitus (bT+) Application of the study treatment may occur at the initial Screening Visit (pending all eligibility requirements can be confirmed) or at Visit 1. The first visit (not including IV lidocaine infusion) should take no more than 3 hour…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: -Age ≥ 18 * Ability to provide informed consent * English speaker * Falls under one of the four groups a. Normal Hearing without Tinnitus (NH/T-) i. Normal Hearing as defined as pure tone thresholds of 25 dB or less across all tested frequencies ii. Subjective confirmation of lack of tinnitus\* 1. Never or rarely b. Normal Hearing with Tinnitus (NH/T+) i. Normal Hearing Normal Hearing as defined as pure tone thresholds of 25 dB or less across all tested frequencies ii. Subjective confirmation of tinnitus\* 1. Often, always c. Unilateral hearing loss and ipsilateral unilat…
Interventions
- DrugIV Lidocaine
IV lidocaine will be administered pre-fMRI and post-FMRI with each subject acting as their own control
Location
- Massachusetts Eye and Ear InfirmaryBoston, Massachusetts