Local Anesthetic

IV Lidocaine for Tinnitus

Q: Are there any available opportunities for individuals to partake in this research?

Data from clinicaltrials.gov confirms that this medical study is still searching for participants, with its initial posting on April 28th 2021 and most recent amendment occurring on August 26th 2022.

Q: Have there been other investigations regarding intravenous lidocaine?

Presently, there are 119 trials for intravenous lidocaine in progress with 31 experiments in the third phase. Calgary, Alberta hosts a few of these studies but you can find over one thousand other sites that are running clinical tests as well.

Q: What purposes is IV Lidocaine typically employed to serve?

Intravenous lidocaine is a popular method for treating cervical syndrome, as well as minor burns, organ <a href="https://www.withpower.com/clinical-trials/transplant">transplant</a>ation, and <a href="https://www.withpower.com/clinical-trials/osteoporosis">osteoporosis</a>.

Q: How many people are actively engaging in this research endeavor?

Affirmative. The information hosted on clinicaltrials.gov suggests that this trial is currently enrolling participants. This clinical research was first published April 28th 2021 and last modified August 26th 2022, with a total of 40 patients across a single location being sought out for enrolment.

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

Falls under one of the four groups:

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

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up60 minutes

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Study Summary

This trial is testing whether IV lidocaine can help doctors understand which brain networks are involved in tinnitus, by temporarily suppressing the tinnitus and observing changes in brain function.

Eligibility Criteria

Inclusion Criteria

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

Select...

You belong to one of the following groups:

Select...

You have normal hearing but also experience ringing in your ears (tinnitus).

Select...

It seems like the criterion you provided is incomplete. Could you please provide more information or context so that I can accurately summarize it?

Select...

You will be asked to rate the frequency of your tinnitus on a scale from "never" to "always."

Select...

You do not have a personal confirmation of experiencing ringing in your ears (tinnitus).

Select...

I'm sorry, but I need more context to properly understand and rewrite the criterion you provided. Could you please provide more information or clarify what you mean by "Never or rarely"?

Select...

You have confirmed that you experience a ringing or buzzing sound in your ears.

Select...

I'm sorry, but I'm not sure what you mean by "Often, always." Could you please provide more context or clarify your question?

Select...

You have hearing loss in one ear and ringing in the same ear.

Select...

You have confirmed hearing ringing or buzzing sounds in your healthy ear.

Select...

I'm sorry, but I'm not sure what "Often, always" refers to in the context of clinical trial exclusion criteria. Could you please provide more information or clarify your question?

Select...

You have hearing loss and ringing in both ears.

Select...

You have confirmed hearing a ringing or buzzing sound in both of your ears.

Select...

I'm sorry, but that is not a complete criterion. Can you please provide more information?

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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 / 14Eligibility criteria met

Find a site

Who is running the clinical trial?

Massachusetts Eye and Ear InfirmaryLead Sponsor

104 Previous Clinical Trials

12,512 Total Patients Enrolled

1 Trials studying Tinnitus

Bradley Welling, MD, PhD4.39 ReviewsPrincipal Investigator - Massachusetts Eye and Ear

Massachusetts Eye and Ear Infirmary

5Patient Review

I'm doing well and life is good, thanks in large part to the care I received from you at OSU.

Media Library

IV Lidocaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04192773 — Phase < 1

Tinnitus Research Study Groups: IV lidocaine

Tinnitus Clinical Trial 2023: IV Lidocaine Highlights & Side Effects. Trial Name: NCT04192773 — Phase < 1

IV Lidocaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04192773 — Phase < 1

Tinnitus Patient Testimony for trial: Trial Name: NCT04192773 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available opportunities for individuals to partake in this research?

"Data from clinicaltrials.gov confirms that this medical study is still searching for participants, with its initial posting on April 28th 2021 and most recent amendment occurring on August 26th 2022."

Answered by AI

Have there been other investigations regarding intravenous lidocaine?

"Presently, there are 119 trials for intravenous lidocaine in progress with 31 experiments in the third phase. Calgary, Alberta hosts a few of these studies but you can find over one thousand other sites that are running clinical tests as well."

Answered by AI

What purposes is IV Lidocaine typically employed to serve?

"Intravenous lidocaine is a popular method for treating cervical syndrome, as well as minor burns, organ transplantation, and osteoporosis."

Answered by AI

How many people are actively engaging in this research endeavor?

"Affirmative. The information hosted on clinicaltrials.gov suggests that this trial is currently enrolling participants. This clinical research was first published April 28th 2021 and last modified August 26th 2022, with a total of 40 patients across a single location being sought out for enrolment."

Answered by AI

Who else is applying?

What state do they live in?

New York

Maine

Massachusetts

Other

How old are they?

65+

18 - 65

What site did they apply to?

Massachusetts Eye and Ear Infirmary

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

What questions have other patients asked about this trial?

Is the travel compensated? HOW LONG DO SCREENING VISIT TAKE? Do you have “satellite locations”?

Patient

Why did patients apply to this trial?

Online search for different treatments/remedies/studies. I have bad tinnitus after cholestoma surgery at 10 years old.

Patient

I HAVE NOT TRIED ANY DRUGS AS MY E.M.T. SAID THERE IS NO EFFECTIVE DRUG FOR TINNITIUS.

Patient

My ears are constantly ringing, I get really mad from it. I want to be ridden of the noise.

Patient

I have had ongoing ringing in my left ear for about 7 months and feel that my right ear has just started doing the same.

Patient

Recent research and studies

clinicaltrials.govStudy

An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus

D. Bradley Welling, MD, PhD 2021. "An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04192773.

~0 spots leftby Nov 2023

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