Investigating how IV lidocaine affects tinnitus using fMRI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This exploratory pilot study aims to examine the effects of intravenous lidocaine on tinnitus by utilizing functional MRI (fMRI) to identify changes in brain activity. A total of 40 participants will be divided into four groups based on their hearing status and presence of tinnitus. Each participant will undergo a baseline assessment, receive an IV lidocaine infusion, and then have follow-up assessments to compare pre- and post-infusion data. The study will collect both functional MRI data and subjective measures of tinnitus perception to identify involved neural networks.

Why it matters

Who can join: the full rules

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

Where it's running

• Massachusetts Eye and Ear Infirmary
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: D. Bradley Welling, MD, PhD — Massachusetts Eye and Ear
• Study coordinator: D. Bradley Welling, MD, PhD
• Email: simonyan_lab@meei.harvard.edu
• Phone: 617-573-6016

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Neck nerve electrical stimulation combined with sound-frequency training for chronic tonal tinnitus

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.