NCT04192773 An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus
| NCT ID | NCT04192773 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | D. Bradley Welling, MD, PhD |
| Condition | Tinnitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-04-28 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2021-04-28 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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\* 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
Contact & Investigator
D. Bradley Welling, MD, PhD
PRINCIPAL INVESTIGATOR
Massachusetts Eye and Ear
Frequently Asked Questions
Who can join the NCT04192773 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tinnitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04192773 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04192773 currently recruiting?
Yes, NCT04192773 is actively recruiting participants. Contact the research team at simonyan_lab@meei.harvard.edu for enrollment information.
Where is the NCT04192773 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04192773 clinical trial?
NCT04192773 is sponsored by D. Bradley Welling, MD, PhD. The principal investigator is D. Bradley Welling, MD, PhD at Massachusetts Eye and Ear. The trial plans to enroll 40 participants.