RECRUITING

An FMRI Investigation of the Effects of IV Lidocaine on Tinnitus

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Conditions

Tinnitusnormal controlhearing lossIV lidocainefMRI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An FMRI Investigation of the Effects of IV Lidocaine on Tinnitus

Quick Facts

Study Start:2021-04-28
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04192773

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to provide informed consent
  2. * English speaker
  3. * 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\*
  4. 1. Often, always
  5. * Tinnitus will be confirmed via Likert-scale: Never - Rarely - Sometimes - Often - Always
  1. * Currently undergoing tinnitus treatment with other pharmacologic agents
  2. * Inability to tolerate fMRI or other contraindications of fMRI including claustrophobia or presence of ferromagnetic objects in the body that cannot be removed.
  3. * Contraindications to IV lidocaine administration such known allergy to lidocaine
  4. * History of myocardial infarction or cardiac arrhythmias including Wolff-Parkinson-White, severe sinoatrial, atrioventricular or intraventricular heart block in the absence of a pacemaker
  5. * History of seizure disorder
  6. * Resting BP of \<100/50
  7. * Currently taking antiarrhythmics
  8. * Have taken antibiotics within 48 hours of infusion
  9. * Known hepatic failure
  10. * Pregnant or lactating women
  11. * Patient with other neurological or psychiatric disorders, such as stroke, brain tumor, schizophrenia, bipolar disorder.
  12. * Patients who cannot fill out the questionnaires

Contacts and Locations

Study Contact

Gaia Arno, MA
CONTACT
617-573-3635
simonyan_lab@meei.harvard.edu
Mikayla K Day, MA
CONTACT
617-573-3635
simonyan_lab@meei.harvard.edu

Principal Investigator

Bradley Welling, MD, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts Eye and Ear

Study Locations (Sites)

Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts Eye and Ear Infirmary

  • Bradley Welling, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts Eye and Ear

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-28
Study Completion Date2024-12

Study Record Updates

Study Start Date2021-04-28
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Tinnitus