DMSO Dual-Route Therapy for Tinnitus

(DART-TINN Trial)

SD
LE
Overseen ByLeading Edge Clinic Practice Manager
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with troublesome tinnitus (ringing in the ears) that began or worsened after long COVID or a COVID-19 vaccine. The treatment, DMSO Dual-Route Therapy, involves applying a special liquid in the ears every four days and a cream around the ears and neck daily for a month. The researchers aim to determine if the treatment can reduce tinnitus by at least half for many participants. This trial suits adults who have experienced tinnitus for at least six months and have tried at least two other treatments without success. All study visits occur online after an initial in-person checkup. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to potentially benefit from an innovative therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

In a previous study, nine out of fifteen patients who used DMSO for tinnitus experienced complete symptom relief, with no recurrence for a year. Another study suggested that using DMSO in low amounts is mostly safe for ear cells. Research has also shown that DMSO can be used in studies without harming the inner ear.

These findings suggest that DMSO is generally safe for ear treatments. However, this therapy remains under investigation, and further research is needed to confirm its safety for everyone. Participants in this trial should be aware of these findings and discuss any concerns with the trial team.12345

Why do researchers think this study treatment might be promising for tinnitus?

Unlike current treatments for tinnitus, which often include sound therapy and medications aimed at symptom relief, DMSO Dual-Route Therapy uses a unique approach with its two-pronged delivery method. This therapy combines a DMSO-based liquid applied to the ear canal and a transdermal cream applied to the skin near the ear and neck. Researchers are excited because DMSO is known for its ability to penetrate tissues and may enhance the delivery of therapeutic agents directly to the affected areas, potentially offering more direct and effective relief from tinnitus symptoms. This dual-route application could provide a novel way to target the condition more precisely than traditional methods.

What evidence suggests that DMSO Dual-Route Therapy might be an effective treatment for tinnitus?

Research suggests that dimethyl sulfoxide (DMSO) might help with tinnitus, a condition characterized by ringing or buzzing in the ears. In one study involving 15 participants, nine experienced complete disappearance of their tinnitus after using DMSO, with no recurrence for at least a year. This trial will evaluate the DMSO Dual-Route Therapy, where all participants will receive a compounded DMSO-based otic liquid and transdermal cream. Known for its ability to penetrate the skin, DMSO may deliver its effects directly to the affected areas. While some studies show promise for DMSO, it is important to note that it is not widely approved for treating tinnitus. More research is needed to fully understand its effectiveness for this condition.12367

Who Is on the Research Team?

SD

Scott D Marsland, MS Nursing

Principal Investigator

Leading Edge Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 18–70 who have had bothersome, non-pulsing tinnitus for at least 6 months after long COVID or a COVID-19 vaccine injury. They must have tried at least two standard treatments without success and be able to attend an initial ENT visit and complete online follow-ups in English.

Inclusion Criteria

I have tried at least two treatments for tinnitus that did not work.
I have had constant ringing in my ears for at least 6 months.
Willing and able to provide informed consent.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (telemedicine), 1 visit (in-person)

Treatment

Participants receive DMSO-based dual-route therapy for 30 days

4 weeks
Regular telemedicine check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Follow-up assessments at 6 and 12 months (telemedicine)

What Are the Treatments Tested in This Trial?

Interventions

  • DMSO Dual-Route Therapy

Trial Overview

The study tests a dual therapy using DMSO-based ear drops (with betahistine, dexamethasone, lidocaine) every 4 days and a DMSO-based cream (with levocarnitine, N-acetylcysteine) applied nightly around the ears/neck for 30 days. All participants receive both treatments.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: DMSO Dual-Route TherapyExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Leading Edge Clinic

Lead Sponsor

Rebuild Medicine Inc

Collaborator

Rebuild Medicine

Collaborator

Citations

DMSO Dual-Route Therapy for Refractory Tinnitus in Long- ...

All participants receive a dual-route regimen for 30 days: (1) a DMSO-based otic liquid instilled into the external auditory canal every 4 days, ...

DMSO Dual-Route Therapy for Refractory Tinnitus in Long ...

Participants have bothersome tinnitus that has not improved with at least two prior standard treatments.

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/1055561/

Dimethyl sulfoxide therapy in subjective tinnitus of ...

Of the fifteen patients treated, the tinnitus symptom completely disappeared in nine, and did not return during a one-year observation period.

DMSO Tinnitus Treatment Study | Leading Edge Clinic

An IRB-approved pilot study investigating DMSO-based treatment for refractory tinnitus in Long COVID and Post-Vaccine Syndrome patients.

Is DMSO (Dimethyl Sulfoxide) effective in treating tinnitus?

There is no evidence supporting the use of DMSO (Dimethyl Sulfoxide) for tinnitus, and it is not mentioned in any established clinical practice ...

Effect of intratympanic dimethyl sulphoxide (DMSO) in an in ...

We suggest that DMSO could be safely used to dissolve hydrophobic compounds in otoprotection studies without interfering with the cochlear damage produced by ...

Cytotoxic effects of dimethyl sulphoxide (DMSO) on cochlear ...

In summary, our results indicate that 24 h treatment with DMSO concentrations of 0.25% or less caused little or no damage to postnatal hair cells in cochlear ...