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Local Anesthetic
IV Lidocaine for Tinnitus
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes
Awards & highlights
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.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes
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 moreTrial 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
Find a Location
Who is running the clinical trial?
Massachusetts Eye and Ear InfirmaryLead Sponsor
106 Previous Clinical Trials
12,909 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have normal hearing but experience ringing in my ears.I do not experience ringing in my ears.I am currently on medication for irregular heartbeats.I hear ringing or noise in my ears that others do not.You cannot tolerate being in a small space for a long time or have metal objects inside your body that cannot be taken out.You are in one of these groups:
a. You can hear normally and don't have tinnitus (ringing in the ears).
b. You can hear normally but have tinnitus.
c. You have hearing loss in one ear and tinnitus in that same ear.
d. You have hearing loss in both ears and tinnitus in both ears.It seems like the criterion is incomplete. Can you please provide more context or clarify the criterion?You are in one of these groups: a. You have normal hearing and no tinnitus b. You have normal hearing and experience tinnitus often or always c. You have hearing loss in one ear and tinnitus in the other ear often or always d. You have hearing loss in both ears and experience tinnitus in both ears often or always. Tinnitus will be confirmed using a Likert scale: Never - Rarely - Sometimes - Often - Always.I either have normal hearing, hearing loss, tinnitus, or both in one or both ears.You will be asked to rate how often you experience tinnitus using a scale from "Never" to "Always".I hear ringing in my good ear.I am 18 years old or older.I am 18 years old or older.I have hearing loss and ringing in the same ear.You have other brain or mental health conditions like stroke, brain tumor, schizophrenia, or bipolar disorder.It seems like the provided text might be incomplete. Can you please provide more context or clarify what you mean by "often, always"?I hear ringing in both of my ears.I am currently taking medication for tinnitus.Your blood pressure when you are not active is lower than 100 over 50.I am not allergic to lidocaine.You belong to one of the following groups:This criterion means that individuals who have never or only very rarely experienced a certain condition are eligible for the study.I have hearing loss and ringing in both ears.I have had a heart attack or serious heart rhythm problems.You have taken antibiotics within 2 days before the treatment.I have a history of seizures.I have been diagnosed with liver failure.
Research Study Groups:
This trial has the following groups:- Group 1: IV lidocaine
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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?
1
0
What questions have other patients asked about this trial?
Is the travel compensated? HOW LONG DO SCREENING VISIT TAKE? Do you have “satellite locations”?
PatientReceived no prior treatments
What does it ie tail in its entirety?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
Online search for different treatments/remedies/studies. I’ve had tinnitus for over 10 years and it’s getting worse.
PatientReceived no prior treatments
I have bad tinnitus after cholestoma surgery at 10 years old. Very interested about if I can get any better with my tinnitus.
PatientReceived no prior treatments
I am tired of the ringing in my ears and they only seem to be getting louder.
PatientReceived no prior treatments
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