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New treatment option for Tinnitus
Official title An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus
ClinicalTrials.gov ID: NCT04192773
What this study is testing
What is IV Lidocaine?
IV Lidocaine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for tinnitus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 tinnitus with IV lidocaine. Patients will include those with hearing loss (both unilateral and bilateral) and tinnitus, subjects with normal hearing and tinnitus, and control subjects with normal hearing and no tinnitus.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- -Age ≥ 18
- Ability to provide informed consent
- English speaker
- Falls under one of the four groups a. Normal Hearing without Tinnitus (NH/T-) i. Normal Hearing as defined as pure tone thresholds of 25 dB or less...
- Often, always
You likely can't join if
- Currently undergoing tinnitus treatment with other pharmacologic agents a. Patients may be eligible if they complete a 60 day washout period from...
- Inability to tolerate fMRI or other contraindications of fMRI including claustrophobia or presence of ferromagnetic objects in the body that cannot...
- Contraindications to IV lidocaine administration such known allergy to lidocaine
- History of myocardial infarction or cardiac arrhythmias including Wolff-Parkinson-White, severe sinoatrial, atrioventricular or intraventricular...
- History of seizure disorder
- Resting BP of \<100/50
See the full eligibility criteria
- -Age ≥ 18
- Ability to provide informed consent
- English speaker
- Falls under one of the four groups a. Normal Hearing without Tinnitus (NH/T-) i. Normal Hearing as defined as pure tone thresholds of 25 dB or less across all tested frequencies ii. Subjective confirmation of lack of...
- Often, always
- Tinnitus will be confirmed via Likert-scale: Never - Rarely - Sometimes - Often - Always
- Currently undergoing tinnitus treatment with other pharmacologic agents a. Patients may be eligible if they complete a 60 day washout period from pharmacologic agents treating tinnitus
- Inability to tolerate fMRI or other contraindications of fMRI including claustrophobia or presence of ferromagnetic objects in the body that cannot be removed.
- Contraindications to IV lidocaine administration such known allergy to lidocaine
- History of myocardial infarction or cardiac arrhythmias including Wolff-Parkinson-White, severe sinoatrial, atrioventricular or intraventricular heart block in the absence of a pacemaker
- History of seizure disorder
- Resting BP of \<100/50
- Currently taking antiarrhythmics
- Have taken antibiotics within 48 hours of infusion
- Known hepatic failure
- Pregnant or lactating women
- Patient with other neurological or psychiatric disorders, such as stroke, brain tumor, schizophrenia, bipolar disorder.
- Patients who cannot fill out the questionnaires
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.