What side effects are associated with this type of intervention?

Common treatments for tinnitus that involve neural activity modulation, such as IV lidocaine, transcranial magnetic stimulation (TMS), and transcutaneous electrical nerve stimulation (TENS), generally have mild side effects. TMS can cause headaches and scalp discomfort, while TENS may lead to skin irritation and discomfort at the electrode sites. These treatments are non-invasive and have not been linked to serious adverse events.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of tinnitus that directly modulate neural activity similar to IV lidocaine. Current treatments for tinnitus primarily focus on managing symptoms through various methods such as sound therapy, cognitive behavioral therapy, and hearing aids. Research is ongoing to explore new treatment modalities, including neuromodulation techniques, but as of now, no such treatments have received FDA approval.

What other types of research exist?

Promising novel alternatives to IV Lidocaine for tinnitus treatment include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in reducing tinnitus symptoms by modulating neural activity. 2) Noninvasive Vagus Nerve Stimulation (nVNS), which may benefit patients by altering neural circuits involved in tinnitus. Both methods have demonstrated potential in clinical trials and could be considered for treatment in 2024.

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Local Anesthetic

IV Lidocaine for Tinnitus

Q: What is the mechanism of action of this treatment?

Common treatments for tinnitus, such as IV lidocaine, transcranial magnetic stimulation (TMS), and neuromodulation devices, work by modulating neural activity. IV lidocaine temporarily suppresses tinnitus by altering neural activity in the auditory pathways, addressing the abnormal neural activity often associated with tinnitus. TMS uses magnetic fields to stimulate nerve cells in the brain, potentially reducing this abnormal activity. Neuromodulation devices, like those used for vagus nerve stimulation, deliver electrical impulses to alter neural activity. These treatments are significant for tinnitus patients as they target the neural mechanisms underlying tinnitus, offering potential relief where traditional therapies may fall short.

Phase < 1

Recruiting

Led By Bradley Welling, MD, PhD

Research Sponsored by Massachusetts Eye and Ear Infirmary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

b. Normal Hearing with Tinnitus (NH/T+)

-Age ≥ 18

Must not have

Currently taking antiarrhythmics

Currently undergoing tinnitus treatment with other pharmacologic agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 minutes

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of IV Lidocaine may include allergic reactions, changes in blood pressure or heart rhythm issues. There's also a risk of neurological symptoms like seizures in susceptible individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have normal hearing but experience ringing in my ears.

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I am 18 years old or older.

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I am 18 years old or older.

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I have hearing loss and ringing in the same ear.

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I have hearing loss and ringing in both ears.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on medication for irregular heartbeats.

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I am currently taking medication for tinnitus.

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I am not allergic to lidocaine.

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I have had a heart attack or serious heart rhythm problems.

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I have a history of seizures.

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I have been diagnosed with liver failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Compare fMRI scans pre- and post-lidocaine administration to identify neural networks associated with chronic tinnitus.

Secondary study objectives

Tinnitus

Change in subjective assessment of tinnitus via Tinnitus Handicap Inventory (THI) questionnaire from baseline to post-infusion.

Change in subjective assessment of tinnitus via Visual Analog Scale (VAS) questionnaire from baseline to post-infusion.

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lidocaine

FDA approved

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for tinnitus, such as IV lidocaine, transcranial magnetic stimulation (TMS), and neuromodulation devices, work by modulating neural activity. IV lidocaine temporarily suppresses tinnitus by altering neural activity in the auditory pathways, addressing the abnormal neural activity often associated with tinnitus. TMS uses magnetic fields to stimulate nerve cells in the brain, potentially reducing this abnormal activity. Neuromodulation devices, like those used for vagus nerve stimulation, deliver electrical impulses to alter neural activity. These treatments are significant for tinnitus patients as they target the neural mechanisms underlying tinnitus, offering potential relief where traditional therapies may fall short.