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An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus

NCT04192773 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-02

No results posted yet for this study

Summary

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

  • Tinnitus

Interventions

DRUG

IV Lidocaine

IV lidocaine will be administered pre-fMRI and post-FMRI with each subject acting as their own control

Sponsors & Collaborators

  • D. Bradley Welling, MD, PhD

    lead OTHER

Principal Investigators

  • D. Bradley Welling, MD, PhD · Massachusetts Eye and Ear

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-28
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04192773 on ClinicalTrials.gov