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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how an IV infusion of lidocaine, a local anesthetic, affects tinnitus, a condition characterized by ringing or buzzing in the ears. Researchers aim to observe changes in the brain using an fMRI scan after treatment. Participants may include individuals with tinnitus and hearing loss, those with tinnitus but normal hearing, and those without tinnitus for comparison. Individuals who frequently experience tinnitus and can undergo an fMRI might be suitable for this study. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking knowledge about tinnitus treatment.

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.

Is there any evidence suggesting that IV lidocaine is likely to be safe for humans?

Research has shown that IV lidocaine can help alleviate tinnitus symptoms. In one study, 19 out of 26 patients reported improvement. However, possible side effects should be noted. Some individuals might experience dizziness or changes in heartbeat. Other common side effects include nausea and lowered blood pressure. Although lidocaine is generally safe, these side effects require close monitoring of patients during treatment to address any issues promptly. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for tinnitus focus on managing symptoms with hearing aids, sound therapy, or cognitive behavioral therapy. But IV lidocaine offers a different approach by directly targeting the neural pathways involved in tinnitus. This treatment is administered intravenously, potentially providing rapid relief, unlike other methods that can take weeks to show results. Researchers are excited because lidocaine’s unique mechanism could offer hope for those who haven't found success with existing options.

What evidence suggests that IV lidocaine might be an effective treatment for tinnitus?

Research has shown that IV lidocaine, the treatment under study in this trial, might help reduce tinnitus symptoms. In one study, 76% of tinnitus patients, particularly those with hearing loss in both ears, felt better after receiving lidocaine. However, results can vary. Another study found that while 40% of participants experienced relief, over 30% reported their tinnitus worsened after treatment. These mixed results suggest that lidocaine can help some people, but it may not work for everyone. Overall, researchers believe that lidocaine might calm the nerves involved in tinnitus, but more research is needed to fully understand its effects. ^{1 2 6 7 8}

Who Is on the Research Team?

Bradley Welling, MD, PhD

Principal Investigator

Massachusetts Eye and Ear

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0385814699000206

Lidocaine test in patients with tinnitus: rationale of ... The lidocaine test showed favorable results in 76% of patients, especially those with bilateral tinnitus (P<0.001). Afterwards, 50% of patients treated with ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/6417606/

Treatment of tinnitus with intravenous lidocaine: a double- ... Although 40% of the lidocaine group reported a decrease in tinnitus, over 30% of the lidocaine group reported increased tinnitus after administration of the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04192773

An fMRI Investigation of the Effects of IV Lidocaine ... 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 ...

4. aao-hnsfjournals.onlinelibrary.wiley.com aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/019459988309100514

Treatment of tinnitus with intravenous lidocaine: A double ... Although 40% of the lidocaine group reported a decrease in tinnitus, over 30% of the lidocaine group reported increased tinnitus after administration of the ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04192773/an-fmri-investigation-of-the-effects-of-iv-lidocaine-on-tinnitus

An FMRI Investigation of the Effects of IV Lidocaine on ... This is an exploratory pilot open-label study to identify the signal changes on fMRI of patients with tinnitus and with temporary ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11124726/

Long-term pain outcomes after serial lidocaine infusion in ... Any adverse effects, such as arrhythmia, dizziness, tinnitus, perioral numbness, tongue paresthesia, and urticarial rash, were documented.

7. journals.lww.com journals.lww.com/otology-neurotology/fulltext/2024/12000/comment_on___intratympanic_lidocaine_as_a_potent.26.aspx

Intratympanic Lidocaine as a Potent Remedy for Tinnitus ... Secondly, although intravenous lidocaine can cause systemic side effects, its therapeutic effect on tinnitus is certain and recommended by guidelines (2).

8. withpower.com withpower.com/trial/early-phase-1-tinnitus-3-2021-f45ee

IV Lidocaine for Tinnitus · Recruiting Participants for Phase ... 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.