Exploring Brain Activity Changes With IV Lidocaine in Adults With and Without Tinnitus Using fMRI

What this Trial Is About

Researchers are studying the effects of intravenous IV lidocaine on tinnitus, a condition where a person hears ringing or buzzing without an external sound. This early-phase, exploratory pilot study aims to observe brain activity changes using functional MRI fMRI in adults with different hearing and tinnitus conditions. The study includes groups with normal hearing and no tinnitus, normal hearing with tinnitus, unilateral hearing loss with tinnitus, and bilateral hearing loss with tinnitus. The goal is to identify neural networks involved in tinnitus and assess subjective changes in tinnitus perception after lidocaine infusion. The study will enroll 40 participants divided equally among the four groups. Each participant will receive an IV lidocaine infusion at a rate of 1000mghour for up to 30 minutes, with a maximum total dose of 500mg. During the infusion, patients are monitored every 5 minutes for vital signs and any side effects. Brain activity will be measured using fMRI before and after the infusion. Audiograms, middle ear reflex tests, and questionnaires assessing tinnitus severity will be completed before and after the lidocaine treatment. Blood samples will be taken to measure lidocaine levels and evaluate liver and kidney function. Participants will attend screening and baseline visits involving MRI scans, hearing tests, questionnaires, blood draws, and an EKG. After the infusion visit, follow-up will be conducted via email about 30 days later to monitor any adverse events and repeat tinnitus questionnaires. The main outcome is to compare brain imaging results before and after lidocaine administration to understand tinnitus-related neural activity. Secondary outcomes include changes in tinnitus severity based on validated questionnaires. Total visit times vary from 3 to 8 hours depending on prior screening completion, and safety and subjective responses will be closely monitored throughout the study.

An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus