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An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus

StatusRecruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Lead sponsor: Massachusetts Eye and Ear Infirmary to D. Bradley Welling, MD, PhD
    • Primary and study completion dates: Dec 2025 to Dec 31, 2027
    v12
  2. Primary completion date: Nov 2024 to Dec 2025
    • Study completion date: Dec 2024 to Dec 2025
    • Site contact updated
    v11
  3. Re-verified, no change to tracked fieldsv10
  4. Site contact updatedv9
  5. Primary completion date: Nov 2023 to Nov 2024
    • Study completion date: Nov 2023 to Dec 2024
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Primary and study completion dates: Nov 2022 to Nov 2023v7
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2020 to Apr 28, 2021
    • Study sites: 0 to 1
    v6
  3. Start date: Aug 2020 to Nov 2020
    • Primary and study completion dates: Jul 2022 to Nov 2022
    v5
  4. Phase: Not applicable to Early Phase 1v4 Show 7 more changesShow less
    • Enrollment target: 20 to 40
    • Primary completion date: Feb 2021 to Jul 2022
    • Start date: May 2020 to Aug 2020
    • Study completion date: Aug 2021 to Jul 2022
    • Interventions: IV Lidocaine (Other) to IV Lidocaine (Drug)
    • Eligibility criteria expanded, about 39 words
    • Study description expanded, about 63 words
  5. Start date: Feb 2020 to May 2020v3
  6. Start date: Dec 2019 to Feb 2020
    • Primary completion date: Dec 2020 to Feb 2021
    • Study completion date: Feb 2021 to Aug 2021
    • Secondary endpoints revised (4)
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04192773
Lead Sponsor D. Bradley Welling, MD, PhD
Conditions
(from sponsor)		 Tinnitus
Related terms Hearing Loss, Tinnitus
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov