Actively Recruiting
An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus
Led by D. Bradley Welling, MD, PhD · Updated on 2025-12-02
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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 1000mg/hour 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.
CONDITIONS
Brief Title
An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ability to provide informed consent
- English speaker
- Falls into one of these groups: a. Normal hearing without tinnitus (pure tone thresholds ≤ 25 dB, tinnitus rarely or never) b. Normal hearing with tinnitus (pure tone thresholds ≤ 25 dB, tinnitus often or always) c. Unilateral hearing loss and ipsilateral unilateral tinnitus (bad ear thresholds ≥ 50 dB, good ear ≤ 25 dB, tinnitus often or always) d. Bilateral hearing loss and bilateral tinnitus (both ears thresholds ≥ 50 dB, tinnitus often or always)
You will not qualify if you...
- Currently undergoing tinnitus treatment with other drugs unless completed a 60-day washout
- Unable to tolerate fMRI or having contraindications like claustrophobia or metal implants
- Allergy to lidocaine
- History of heart attack, cardiac arrhythmias, or severe heart block without pacemaker
- History of seizure disorder
- Resting blood pressure below 100/50
- Taking antiarrhythmic medications
- Taken antibiotics within 48 hours before infusion
- Known liver failure
- Pregnant or breastfeeding women
- Having neurological or psychiatric disorders such as stroke, brain tumor, schizophrenia, or bipolar disorder
- Unable to complete study questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 2 visits depending if screening and baseline assessments are done together or separately
Duration - 1 day
Participants receive a 30-minute IV lidocaine infusion while undergoing fMRI and other assessments before and after infusion to evaluate effects on tinnitus.
1 infusion visit lasting up to 5 hours if screening was completed earlier, or up to 8 hours if screening occurs same day
Duration - Approximately 1 month
Participants are followed up by email about 30 days after infusion to report any adverse events and complete questionnaires assessing tinnitus.
1 follow-up via email
Trial Site Locations
Total: 1 location
1
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
D
D. Bradley Welling, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here