Investigating how IV lidocaine affects tinnitus using fMRI
An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus
This study is testing if an IV lidocaine treatment can change brain activity and help people with tinnitus feel better.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts Eye and Ear Infirmary Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04192773 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with varying degrees of hearing loss and tinnitus, as well as individuals with normal hearing and tinnitus.
Not a fit: Patients with conditions unrelated to tinnitus or those who do not meet the specific hearing criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new insights into the neural mechanisms of tinnitus and potential therapeutic approaches for its management.
How similar studies have performed: While this approach is exploratory, previous studies have indicated potential benefits of lidocaine in managing tinnitus, suggesting a promising avenue for further investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.