Actively Recruiting
An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus
Led by D. Bradley Welling, MD, PhD · Updated on 2025-12-02
40
Participants Needed
1
Research Sites
348 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older
- Ability to give informed consent
- English speaker
- Must be in one of these groups: normal hearing without tinnitus; normal hearing with tinnitus; unilateral hearing loss with tinnitus on the same side; bilateral hearing loss with bilateral tinnitus
- Normal hearing defined as pure tone thresholds of 25 dB or less across all tested frequencies
- Subjective tinnitus confirmation using Likert scale (Never - Rarely - Sometimes - Often - Always)
You will not qualify if you...
- Currently receiving pharmacologic treatment for tinnitus unless a 60-day washout period is completed
- Unable to tolerate fMRI or has contraindications like claustrophobia or unremovable metal in body
- Known allergy to lidocaine
- History of heart attack or certain serious heart rhythm problems without pacemaker
- History of seizure disorder
- Resting blood pressure below 100/50
- Currently taking antiarrhythmic drugs
- Taken antibiotics within 48 hours prior to infusion
- Known liver failure
- Pregnant or breastfeeding women
- Other neurological or psychiatric disorders such as stroke, brain tumor, schizophrenia, bipolar disorder
- Unable to complete study questionnaires
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
D
D. Bradley Welling, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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