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RecruitingAccepts healthy volunteersEarly Phase 1

An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus

D. Bradley Welling, MD, PhD · NCT04192773

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Early Phase 1
Target enrollment
40
US sites recruiting
1
Study start
April 28, 2021
Record last updated
December 2, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: IV Lidocaine

Conditions: Tinnitus

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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*
  • 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

Recruiting US locations

  • Massachusetts Eye and Ear Infirmary

    Boston, MA 02114

    Site contact: Azadeh Hamzehei Sichani, MD, PhD · 617-573-6016 · simonyan_lab@meei.harvard.edu

Study contacts (from the official record)

  • D. Bradley Welling, MD, PhD · 617-573-6016 · simonyan_lab@meei.harvard.edu
All healthy volunteers studies in Massachusetts →
An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus (NCT04192773) | Bored Studies