An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus

Launched by MASSACHUSETTS EYE AND EAR INFIRMARY · Dec 9, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring how a medication called IV lidocaine may affect tinnitus, which is the perception of noise or ringing in the ears. Researchers want to see how lidocaine can temporarily reduce tinnitus symptoms and how this change shows up in brain scans using a technique called fMRI. The study will involve different groups of people: those with normal hearing who experience tinnitus, those with hearing loss and tinnitus, and individuals with normal hearing who do not have tinnitus.

Adults aged 18 and older who can speak English and are experiencing tinnitus or have normal hearing may be eligible to participate. Participants will first complete questionnaires and undergo a brain scan. Then, they will receive an IV infusion of lidocaine and have another scan after the treatment to compare results. It’s important to note that some individuals, such as those currently receiving other tinnitus treatments or with certain medical conditions, may not be able to join the study. This trial is currently recruiting participants, and it aims to better understand how tinnitus affects the brain and how medications might help alleviate the symptoms.

Gender

ALL

Eligibility criteria

• 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