Clinical trial: An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus (NCT04192773)

Eligibility criteria:
Inclusion 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 tinnitus* 1. Never or rarely b.
             Normal Hearing with Tinnitus (NH/T+) i. Normal Hearing Normal Hearing as defined as
             pure tone thresholds of 25 dB or less across all tested frequencies ii. Subjective
             confirmation of tinnitus* 1. Often, always c. Unilateral hearing loss and ipsilateral
             unilateral tinnitus (uHL/uT+) i. Unilateral hearing loss as defined by pure tone
             thresholds of 50 dB or greater across 3 frequencies in the bad ear and 25 dB or less
             in good ear ii. Subjective confirmation of tinnitus in the good ear* 1. Often, always
             d. Bilateral hearing loss and bilateral tinnitus (bHL/bT+) i. Bilateral hearing loss
             as defined by pure tone thresholds of 50 dB or greater across 3 frequencies in both
             ears ii. Subjective confirmation of tinnitus in both ears*

               1. Often, always

                    -  Tinnitus will be confirmed via Likert-scale: Never - Rarely - Sometimes -
                       Often - Always

        Exclusion Criteria:

          -  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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old woman comes to the clinic complaining of dizziness.  She also has occasional nausea and ringing in her right ear.  The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal.  The dizziness improves spontaneously, and she feels fine between episodes.  Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl.  She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago.

Patient description (patient's own words): The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now.

Does the patient match the trial criteria? Entailment