Lidocaine injection reveals tinnitus brain networks in tiny pilot
NCT ID NCT04192773
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study will give IV lidocaine to 40 adults with or without tinnitus and hearing loss, then use fMRI to see how the drug changes brain activity. Participants act as their own control, comparing scans before and after the infusion. The goal is to identify neural networks linked to chronic tinnitus, not to test a treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IV lidocaine
- What this could lead to
- If successful, this could help identify brain networks involved in tinnitus, pointing toward future targeted treatments.
- What could go wrong
- This is a very early, small pilot study (40 people) with no control group. It is designed to explore brain changes, not to test a treatment, so results may not lead to any therapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2021
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 unilateral tinnitus (uHL/uT+) i. Unilateral hearing loss as defined by pure tone thresholds of 50 dB or greater across 3 frequencies in the bad ear and 25 dB or less in good ear ii. Subjective confirmation of tinnitus in the good ear\* 1. Often, always d. Bilateral hearing loss and bilateral tinnitus (bHL/bT+) i. Bilateral hearing loss as defined by pure tone thresholds of 50 dB or greater across 3 frequencies in both ears ii. Subjective confirmation of tinnitus in both ears\* 1. Often, always * Tinnitus will be confirmed via Likert-scale: Never - Rarely - Sometimes - Often - Always Exclusion Criteria: * Currently undergoing tinnitus treatment with other pharmacologic agents a. Patients may be eligible if they complete a 60 day washout period from pharmacologic agents treating tinnitus * Inability to tolerate fMRI or other contraindications of fMRI including claustrophobia or presence of ferromagnetic objects in the body that cannot be removed. * Contraindications to IV lidocaine administration such known allergy to lidocaine * History of myocardial infarction or cardiac arrhythmias including Wolff-Parkinson-White, severe sinoatrial, atrioventricular or intraventricular heart block in the absence of a pacemaker * History of seizure disorder * Resting BP of \<100/50 * Currently taking antiarrhythmics * Have taken antibiotics within 48 hours of infusion * Known hepatic failure * Pregnant or lactating women * Patient with other neurological or psychiatric disorders, such as stroke, brain tumor, schizophrenia, bipolar disorder. * Patients who cannot fill out the questionnaires
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Massachusetts Eye and Ear Infirmary
RECRUITINGBoston, Massachusetts, 02114, United States
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Other studies related to the condition(s) this trial covers.
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- Could a patch behind the ear silence tinnitus?