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IV Lidocaine for Tinnitus Study

This study is exploring how intravenous (IV) lidocaine affects brain activity in people with tinnitus. Researchers will give participants IV lidocaine and then use fMRI (functional magnetic resonance imaging), a type of brain scan, to see how brain networks change. The study includes people with normal hearing, people with normal hearing and tinnitus, and people with hearing loss and tinnitus. The goal is to understand which brain networks are involved in chronic tinnitus by observing changes after lidocaine temporarily reduces tinnitus symptoms. The study is currently unclear on its recruitment status.

Study design
This is an exploratory, open-label study involving 40 participants. You would act as your own control, meaning your brain activity will be measured before and after receiving IV lidocaine.
What's involved
You would have a screening visit that could take up to 8 hours, including questionnaires, hearing tests, and a baseline MRI. The visit where you receive IV lidocaine and have fMRI scans could take up to 5 hours.
Compensation
Not stated in the trial record.
Follow-up
Your brain activity will be measured 60 minutes after lidocaine administration to compare changes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04192773

An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus

Recruiting
EARLY_PHASE1Ages 18+InterventionalDiagnostic
D. Bradley Welling, MD, PhD
~40 participants
Updated 2025-12-02 on ClinicalTrials.gov
What's tested:IV Lidocaine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Compare fMRI scans pre- and post-lidocaine administration to identify neural networks associated with chronic tinnitus.
Measured over 60 MINUTES

Conditions

Tinnitus

Explore related trials

Hearing LossTinnitus

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • D. Bradley Welling, MD, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts Eye and Ear

Who to contact

D. Bradley Welling, MD, PhD
[email protected]
617-573-6016
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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\*
Tinnitus will be confirmed via Likert-scale: Never - Rarely - Sometimes - Often - Always

Exclusion

Currently undergoing tinnitus treatment with other pharmacologic agents
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

What this trial measures

  • Compare fMRI scans pre- and post-lidocaine administration to identify neural networks associated with chronic tinnitus.60 MINUTES

    The investigators will scan the patient in fMRI prior to IV lidocaine administration. After the infusion, patient will get another fMRI scan to assess any neural changes in the primary auditory cortex and associated salience, limbic and cognitive regions.