IV Lidocaine for Tinnitus

Recruiting in Palo Alto (17 mi)

Overseen ByBradley Welling, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Massachusetts Eye and Ear Infirmary

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing if giving lidocaine through an IV can temporarily reduce tinnitus. It includes patients with and without hearing loss. The goal is to see if lidocaine changes brain activity related to tinnitus. Lidocaine has been studied for its potential to temporarily relieve tinnitus, but its clinical use is limited due to brief effects and side effects.

Eligibility Criteria

This trial is for adults who can consent and speak English, with or without tinnitus and varying hearing abilities. It includes those with normal hearing, unilateral or bilateral hearing loss combined with tinnitus. People undergoing other tinnitus treatments, unable to undergo fMRI scans, pregnant women, individuals on certain medications like antiarrhythmics or recent antibiotics users are excluded.

Inclusion Criteria

I have normal hearing but experience ringing in my ears.

I do not experience ringing in my ears.

I hear ringing or noise in my ears that others do not.

+16 more

Exclusion Criteria

I am currently on medication for irregular heartbeats.

You cannot tolerate being in a small space for a long time or have metal objects inside your body that cannot be taken out.

Patients who cannot fill out the questionnaires

+9 more

Participant Groups

The study tests how IV Lidocaine affects brain activity in people with tinnitus using fMRI scans before and after the infusion. The goal is to see if Lidocaine temporarily suppresses tinnitus and identify which parts of the brain are involved by comparing data from different participant groups.

1Treatment groups

Experimental Treatment

Group I: IV lidocaineExperimental Treatment1 Intervention

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.