Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
NCT04192773

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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)
Not Eligible

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

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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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