**”Clinical Trial: New Alzheimer’s Treatment”**

A New Pilot Trial Tests DMSO for Tinnitus Linked to Long-COVID and Vaccine Injury

A new clinical trial is preparing to test an old compound for a modern problem: persistent tinnitus after COVID-19 or vaccination. The single-arm pilot study, identified as NCT07567274, will enroll 20 adults to evaluate a dual-route therapy using compounded dimethyl sulfoxide (DMSO). The goal is to see if this approach can reduce the burden of tinnitus for patients who have found no relief from standard treatments.

What the Trial Involves: Design, Treatment, and Participants

This is a prospective, open-label, single-arm study. Every participant will receive the same 30-day intervention. The therapy involves two compounded formulations prepared by a licensed pharmacy: a DMSO-based otic liquid for the ear canal and a DMSO-based transdermal cream for the skin around the ears and upper neck. Patients will use the ear drops every four days and apply the cream once daily at bedtime.

The main question researchers want to answer is whether at least half of the participants (10 out of 20) achieve a clinically meaningful improvement. Success is defined as a 50% or greater reduction in the Tinnitus Handicap Inventory (THI) score from baseline to Day 30. Secondary measures include changes in perceived tinnitus loudness and annoyance, effects on sleep and concentration, and associated symptoms like vertigo, insomnia, headache, and fatigue. Safety monitoring for side effects is a key component.

Eligibility is specific. Participants must be between 18 and 70 years old with chronic, bothersome tinnitus (THI score ≥20) for at least six months. Crucially, they must have a documented history of long-COVID (PASC) or post-COVID-19 vaccine injury, with their tinnitus clearly starting or worsening after that event. They must also have tried and failed at least two prior standard tinnitus therapies, such as sound therapy, counseling, or medications.

After an initial in-person ear, nose, and throat (ENT) evaluation, the entire study is managed remotely. Participants complete all follow-up visits via telemedicine and submit electronic questionnaires through a secure, HIPAA-compliant system for a total of 12 months.

The Scientific Rationale Behind Using DMSO

Subjective tinnitus is a frequent and distressing symptom reported in long-COVID and post-vaccine injury cases. Proposed mechanisms involve neuroinflammation, microvascular dysfunction, oxidative stress, and mitochondrial impairment within auditory pathways. For many, standard options provide little benefit, and no FDA-approved drug exists to cure chronic subjective tinnitus.

Dimethyl sulfoxide (DMSO) is a solvent derived from wood pulp. It has documented anti-inflammatory, antioxidant, and vasodilatory properties. It also acts as a penetration enhancer, which could help other therapeutic agents reach target tissues. The rationale for this trial is not new. An open-label study from the 1970s reported that DMSO-based formulations combined with other agents led to improvement or resolution of subjective tinnitus in a majority of treated patients. This new pilot trial seeks to modernize that historical approach using current pharmaceutical compounding standards and apply it specifically to refractory cases within the long-COVID and post-vaccine injury populations.

Current Status and Future Implications

As of the latest update, the trial status is “NOT_YET_RECRUITING.” The research team is preparing to enroll the target of 20 participants. As a Phase 2 pilot study, its purpose is to gather initial data on safety and signal of efficacy to inform the potential design of larger, controlled future trials.

If the intervention shows promise, it could offer a new direction for managing a symptom that significantly reduces quality of life for these patients. A positive outcome would justify more rigorous, placebo-controlled studies. Furthermore, the telemedicine-based follow-up model demonstrates a practical approach for conducting longer-term monitoring of chronic conditions. For the field, this trial represents a direct test of a historical hypothesis in a novel and growing patient population with high unmet medical need.

This article is for informational purposes only. Consult a qualified professional for personalised advice.

Source:
DMSO Dual-Route Therapy for Refractory Tinnitus in Long-COVID and Post-COVID-19 Vaccine Injury (ClinicalTrials.gov: NCT07567274)