An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus

NCT04192773 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 2019P0002539
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

tinnitus; normal control; hearing loss; IV lidocaine; fMRI

Outcome Measures

Primary Outcomes (1)

• Compare fMRI scans pre- and post-lidocaine administration to identify neural networks associated with chronic tinnitus.

  The investigators will scan the patient in fMRI prior to IV lidocaine administration. After the infusion, patient will get another fMRI scan to assess any neural changes in the primary auditory cortex and associated salience, limbic and cognitive regions.

  60 MINUTES

Secondary Outcomes (4)

• Change in subjective assessment of tinnitus via Tinnitus Handicap Inventory (THI) questionnaire from baseline to post-infusion.

  30 MINUTES

• Change in subjective assessment of tinnitus via Tinnitus Functional Index (TFI) questionnaire from baseline to post-infusion.

  30 MINUTES

• Change in subjective assessment of tinnitus via Visual Analog Scale (VAS) questionnaire from baseline to post-infusion.

  30 MINUTES

• Compare blood oxygen level (O2) dependent signal derived from pre- and post-infusion fMRI.

  30 MINUTES

Study Arms (1)

IV lidocaine

EXPERIMENTAL

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.

Drug: IV Lidocaine

Interventions

IV Lidocaine DRUG

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

IV lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• D. Bradley Welling, MD, PhD: lead

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Tinnitus; Hearing Loss

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• D. Bradley Welling, MD, PhD

  Massachusetts Eye and Ear

  PRINCIPAL INVESTIGATOR

Central Study Contacts

D. Bradley Welling, MD, PhD

CONTACT

617-573-6016; simonyan_lab@meei.harvard.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Otolaryngology-Head and Neck Surgery

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: December 10, 2019
• Study Start: April 28, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

US (1)