Early Phase 1 Hearing Loss Trial, Recruiting NCT04192773 Sponsor: D. Bradley Welling, MD, PhD Condition: Hearing Loss
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Early Phase 1 Hearing Loss Trial, Recruiting

NCT04192773
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older
  • People who are able to give informed consent to participate
  • People who speak English
  • People who fall into one of four hearing and tinnitus groups:
    • Group 1: Normal hearing in both ears and no tinnitus (tinnitus reported as "never" or "rarely")
    • Group 2: Normal hearing in both ears and tinnitus that is present often or always
    • Group 3: Significant hearing loss in one ear only, with tinnitus in that same ear occurring often or always, and normal hearing in the other ear
    • Group 4: Significant hearing loss in both ears, with tinnitus in both ears occurring often or always

Who may not be able to join:

  • People currently receiving medication-based treatment for tinnitus (though people who have stopped such medications for at least 60 days may still be considered — confirm with trial site)
  • People who are unable to tolerate an MRI scan, or who have claustrophobia, or who have metal objects in their body that cannot be removed
  • People who have a known allergy to lidocaine or other reasons they cannot safely receive it by IV
  • People with a history of heart attack, or certain heart rhythm problems (such as Wolff-Parkinson-White syndrome or serious heart block), unless they have a pacemaker
  • People with a history of seizures or epilepsy
  • People whose resting blood pressure is below 100/50
  • People currently taking medications that treat heart rhythm problems (antiarrhythmics)
  • People who have taken antibiotics within 48 hours before the infusion
  • People with known liver failure
  • People who are pregnant or breastfeeding
  • People with other neurological or psychiatric conditions, such as stroke, brain tumour, schizophrenia, or bipolar disorder
  • People who are unable to complete questionnaires

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: D. Bradley Welling, MD, PhD, Massachusetts Eye and Ear

Phone: 617-573-6016

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Early Phase 1
Sponsor
D. Bradley Welling, MD, PhD
Registry
ClinicalTrials.gov
Start date
28 April 2021
Est. completion
31 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov