An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus
Key facts
- Who runs it
- D. Bradley Welling, MD, PhD
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Early phase 1
- People taking part
- 40 people, planned
- Started
- 28 Apr 2021
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional
- Treatments tested
- IV Lidocaine
- Record updated
- 2 December 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- -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*; Often, always; Tinnitus will be confirmed via Likert-scale: Never - Rarely - Sometimes - Often - Always
Who cannot take part
- Currently undergoing tinnitus treatment with other pharmacologic agents; Patients may be eligible if they complete a 60 day washout period from pharmacologic agents treating tinnitus
- Currently taking antiarrhythmics
- 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
- Known hepatic failure
- Patient with other neurological or psychiatric disorders, such as stroke, brain tumor, schizophrenia, bipolar disorder
- Inability to tolerate fMRI or other contraindications of fMRI including claustrophobia or presence of ferromagnetic objects in the body that cannot be removed
- Resting BP of <100/50
- Have taken antibiotics within 48 hours of infusion
- Pregnant or lactating women
- Patients who cannot fill out the questionnaires
Where in United States
- Massachusetts Eye and Ear InfirmaryBoston, United StatesContact: Azadeh Hamzehei Sichani, MD, PhDTaking people
About the trial
What the trial wants to find out
This is an exploratory pilot open-label study to identify the signal changes on fMRI of patients with tinnitus and with temporary suppression of the tinnitus with IV lidocaine. Patients will include those with hearing loss (both unilateral and bilateral) and tinnitus, subjects with normal hearing and tinnitus, and control subjects with normal hearing and no tinnitus. Eligible subjects will have functional and subjective data collected at baseline, receive an IV lidocaine infusion, and have functional and subjective data collected post-infusion for comparison and identification of involved neural networks.
The group in the trial
- IV lidocaineTreatment being tested
1000mg/hour IV lidocaine administered for up to 30 minutes (500mg max). Patients will be continuously monitored by a nurse every 5 (±2) minutes to check specifically for vital signs (BP, HR, and RR), patient tinnitus levels, and reports of side effects. The infusion is continued until any of the following criteria are met: 1) the patient has completed the 30-minute infusion; 2) the patient reports intolerable or concerning side effect, such as dizziness, nausea, or vomiting; 3) the patient experiences bradycardia \<50 and a drop of systolic blood pressure (BP) more than 20 mmHg and diastolic pressure more than 10 mmHg during the infusion; 4) the patient reports that tinnitus is resolved, or 5) the patient wishes to stop the study. Serum lidocaine levels will be drawn by a research nurse upon completion of MRI. The Tinnitus Handicap Inventory, the Tinnitus Functional Index, and the Visual Analog Scale will be administered after IV infusion.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 2 December 2025