Health TrialsbyHealthPanel

An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus

ConditionTinnitus
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorD. Bradley Welling, MD, PhD

About this trial

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. Eligible subjects will have functional and subjective data collected at baseline, receive an IV lidocaine infusion, and have functional and subjective data collected post-infusion for comparison and identification of involved neural networks.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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*

Often, always

Disqualifiers

Currently undergoing tinnitus treatment with other pharmacologic agents

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

Trial design

Design model

Single group

Treatments tested in this trial

  • IV Lidocaine

    Drug

    IV lidocaine will be administered pre-fMRI and post-FMRI with each subject acting as their own control

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: IV lidocaineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

The investigators will scan the patient in fMRI prior to IV lidocaine administration. After the infusion, patient will get another fMRI scan to assess any neural changes in the primary auditory cortex and associated salience, limbic and cognitive regions.

Time frame
60 MINUTES

Secondary outcomes

1

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

Patients will be given the questionnaire at baseline to evaluate their tinnitus. The purpose of this questionnaire is to identify difficulties that patients may be experiencing because of their tinnitus. The patients can choose to answer "yes", "sometimes", and "no" to these questions. The higher scores mean worse outcome. The same questionnaire will be given after the infusion to compare questionnaire responses.

Time frame
30 MINUTES
2

Change in subjective assessment of tinnitus via Tinnitus Functional Index (TFI) questionnaire from baseline to post-infusion.

Patients will be given the questionnaire at baseline to evaluate their tinnitus. Multiple questions probing how the patient's tinnitus has affected different social aspects of their lives are evaluated on the scale of 0 to 10. The higher scores indicate a worse outcome. The same questionnaire will be given after the infusion to compare questionnaire responses.

Time frame
30 MINUTES
3

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

Patients will be given the questionnaire at baseline to evaluate their tinnitus. The scale evaluates tinnitus loudness, annoyance felt by the patient due to the tinnitus, distress experienced by the patient, and his/her ability to cope with tinnitus. The scale is 10cm long, labeled with 'min' on the left side and 'max' on the right side. Higher scores on the first three categories mean worse outcomes and lower score on the ability to cope means worse outcome. The same questionnaire will be given after the infusion to compare questionnaire responses.

Time frame
30 MINUTES
4

Compare blood oxygen level (O2) dependent signal derived from pre- and post-infusion fMRI.

The investigators will compare measured blood O2 level dependent activity on fMRI images pre- and post-infusion.

Time frame
30 MINUTES

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

D. Bradley Welling, MD, PhD

Lead sponsor

Massachusetts Eye and Ear Infirmary

Sponsor institution

Source ClinicalTrials.gov
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