Recruiting
Early Phase 1

Lidocaine

Sponsor:

D. Bradley Welling, MD, PhD

Code:

NCT04192773

Conditions

Tinnitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

IV Lidocaine

Study Details

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

Study ID

NCT04192773

Start date

Apr 28, 2021

Status verified date

Nov, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

-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\*

1. Often, always

  • Tinnitus will be confirmed via Likert-scale: Never - Rarely - Sometimes - Often - Always

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: IV lidocaine

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.

Interventions

IV Lidocaine

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

Primary outcome measure

  • Compare fMRI scans pre- and post-lidocaine administration to identify neural networks associated with chronic tinnitus. [ Time Frame: 60 MINUTES ]

Central Contacts and Locations

Central contacts

D. Bradley Welling, MD, PhD

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

Locations

Massachusetts Eye and Ear Infirmary

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Azadeh Hamzehei Sichani, MD, PhD

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

Principal Investigator:

D. Bradley Welling, MD, PhD

More Information

Sponsor

D. Bradley Welling, MD, PhD

Last update posted

Dec 2, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by D. Bradley Welling, MD, PhD on 2025-12-02.