IV Lidocaine for Tinnitus

Overseen By Mikayla K Day, MA

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Massachusetts Eye and Ear Infirmary

Must not be taking: Antiarrhythmics, Antibiotics

Disqualifiers: Seizure disorder, Cardiac arrhythmias, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

40 Participants Needed

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.

Will I have to stop taking my current medications?

If you are currently taking medications for tinnitus, you will need to stop them for a 60-day period before joining the trial. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug IV Lidocaine for treating tinnitus?

Some studies suggest that IV lidocaine can temporarily reduce tinnitus symptoms in some patients, with one study showing improvement in 19 out of 26 patients. However, the results are mixed, as another study found that while 40% of patients reported improvement, over 30% experienced worsening symptoms, and there were notable side effects. ^{1 2 3 4 5}

Is IV lidocaine safe for treating tinnitus?

IV lidocaine can cause side effects like disequilibrium (balance problems), slurred speech, numbness, and tingling in the limbs. While it may help some people with tinnitus, these side effects suggest it might not be safe for everyone. ^{1 2 4 6 7}

How does the drug IV lidocaine differ from other treatments for tinnitus?

IV lidocaine is unique because it is administered directly into the bloodstream and has been shown to temporarily reduce tinnitus in some patients, although it can also cause side effects like dizziness and numbness. Unlike other treatments, its effects are short-lived, and it works by potentially affecting the auditory pathways in the brain. ^{1 2 4 6 8}

Research Team

Bradley Welling, MD, PhD

Principal Investigator

Massachusetts Eye and Ear

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Baseline Assessment

Baseline MRI, audiometry, middle ear muscle reflexes, and questionnaires (THI, TFI, VAS) are conducted

1 day

1 visit (in-person)

Treatment

IV lidocaine infusion for 30 minutes with continuous monitoring, followed by post-infusion fMRI and questionnaires

1 day

1 visit (in-person)

Follow-up

Participants are followed up via email 30 days post-infusion to assess adverse events and complete questionnaires

30 days

Remote follow-up

Treatment Details

Interventions

• IV Lidocaine

Trial Overview 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.

Participant Groups

Group I: IV lidocaine Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials

115

Recruited

15,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Lidocaine in the treatment of tinnitus aurium. A double-blind study. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Treatment of tinnitus with intravenous lidocaine: a double-blind randomized trial. [2017]

3. Germany pubmed.ncbi.nlm.nih.gov

[Antiarrhythmic agents in tinnitus treatment]. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

The inhibitory effect of intravenous lidocaine infusion on tinnitus after translabyrinthine removal of vestibular schwannoma: a double-blind, placebo-controlled, crossover study. [2019]

5. England pubmed.ncbi.nlm.nih.gov

I.V. ropivacaine compared with lidocaine for the treatment of tinnitus. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Lidocaine intradermal injection--a new approach in tinnitus therapy: preliminary report. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

[Treatment of tinnitus with lidocaine? A report of clinical experiences]. [2019]

8. Japan pubmed.ncbi.nlm.nih.gov

[Treatment of tinnitus with intravenous lidocaine]. [2019]