DART-TINN: A clinical study for Long COVID and Post-Vaccine Syndrome tinnitus
Investigating a novel DMSO-based treatment for adults with refractory tinnitus linked to Long COVID or post-COVID-19 vaccine injury
ABOUT THE STUDY
What is the DART-TINN study?
Leading Edge Clinic is sponsoring the DART-TINN study — a prospective, IRB-approved pilot clinical trial for adults with chronic tinnitus that has not responded to standard treatment, where that tinnitus is linked to Long COVID (PASC) or post-COVID-19 vaccine injury.
The study is conducted in collaboration with Rebuild Medicine, a nonprofit dedicated to the research and application of repurposed medicines. Scott Marsland, FNP-C — co-founder of Leading Edge Clinic — serves as principal investigator.
This is a pilot study designed to generate a preliminary signal and establish safety and feasibility — not to prove efficacy. Results will inform the design of a larger, controlled trial.
View full protocol on ClinicalTrials.gov →
Leading Edge ClinicSponsor · Principal investigator
× Rebuild MedicineCollaborating nonprofit
Principal Investigator
ELIGIBILITY
Patient Qualifications
Eligibility Criteria Includes:
- Are between 18 and 70 years of age
- Have had chronic, non-pulsatile tinnitus for at least 6 months
- Have Long COVID (PASC) or post-COVID-19 vaccine injury, with tinnitus onset linked to that event
- Have tried at least two prior tinnitus treatments without adequate relief
- Have a Tinnitus Handicap Inventory (THI) score of 20 or higher
- Can complete telemedicine visits and questionnaires in English
- Can attend a one-time in-person ENT evaluation
Exclusion Criteria:
- Pulsatile tinnitus (tinnitus that beats with your heartbeat)
- Active ear infection, tympanic membrane perforation, or ear discharge
- Known allergy to DMSO or study formulation components
- Recent exposure to ototoxic medications within the past 3 months
- Current pregnancy or breastfeeding
- Uncontrolled or severe psychiatric illness
- Other otologic or neurologic conditions that confound tinnitus assessment
PARTICIPATION
How Participation Works
Screening
Confirm eligibility and complete informed consent
ENT evaluation
One-time in-person visit with a local ENT. We write the referral.
30-day treatment
Compounded formulations at home with regular telemedicine check-ins
Follow up
Assessments at Day 30, Month 6, and Month 12
Cost Transparency
Participants are responsible for the cost of study interventions, including compounded formulations and clinical visits. Exact costs are discussed with Leading Edge Clinic.
FAQ
Frequently Asked Questions
Do I have to come in person anywhere?
Only once — for the baseline ENT evaluation before the treatment period begins. All other visits are conducted via telemedicine. We write the ENT referral to a provider local to you.
What does the treatment actually involve?
Participants receive two compounded formulations prepared by a licensed pharmacy. One is applied to the ear canal every 4 days. The other is a cream applied once daily to the skin around and behind the ears and upper neck. Both are used for 30 days.
Can I keep seeing my regular doctors while participating?
Yes. We encourage all participants to maintain relationships with their existing healthcare providers. Standard tinnitus counseling and sound therapy are also permitted. No new tinnitus-specific medications may be started during the 30-day treatment window.
What if I experience a side effect?
Safety is monitored throughout the study. The study team is available via telemedicine for any concerns. Expected DMSO-related effects — such as a transient garlic-like odor or mild skin warmth — are anticipated and documented. Any unexpected or concerning effects are reviewed promptly.
What happens after the 30 days?
The treatment period ends at Day 30, but follow-up continues. You’ll complete questionnaires and telemedicine check-ins at 6 months and 12 months to assess whether any improvement holds over time.
I don't think I qualify — can I still get help for my tinnitus?
Yes. Even if you don’t meet the enrollment criteria, our clinical team will help identify other approaches within your broader Long COVID or Post-Vaccine Syndrome care plan.
Where can I read more about the science behind this study?
We’ve written a detailed blog post covering the mechanisms of Long COVID tinnitus, why standard treatments often fail this population, and the rationale behind the DART-TINN study.
Track DART-TINN Study
For updates on recruitment, tracking, results, and publishing, visit the ClinicalTrials.gov page, or contact the study team.
PHONE
800-381-9167 ext. 410
About Rebuild Medicine
Rebuild Medicine is a nonprofit dedicated to funding and conducting research on repurposed medicines and underinvestigated therapeutic approaches. DART-TINN is one of several active studies conducted in collaboration with Rebuild Medicine and Leading Edge Clinic.
Also in our research program
Leading Edge Clinic is the sponsor of the DART-TINN study. Principal investigator: Scott Marsland, FNP-C. Conducted in collaboration with Rebuild Medicine. IRB approval: IMIRB-202600105. Study participation requires informed consent and eligibility screening. This page does not constitute medical advice.
