What side effects are associated with this type of intervention?

Common treatments for chronic rhinitis involving neuromodulation or targeted nerve stimulation, such as noninvasive vagus nerve stimulation (nVNS), have been associated with mild side effects. These include a warm sensation, arm or hand numbness, redness, itching, tingling, muscle spasm, arm pain, shoulder pain, and neck pain. No serious adverse events have been reported in the context of these treatments.

What prior FDA approvals exist?

The FDA has approved various treatments for chronic rhinitis, including pharmacologic therapies like antihistamines, nasal corticosteroids, and immunotherapy. However, in terms of neuromodulation or targeted nerve stimulation, the FDA has approved devices such as the remote electrical neuromodulation device for migraine, which may have similar mechanisms of action. These devices aim to alleviate symptoms by modulating nerve activity, although specific approvals for chronic rhinitis using this technology are not detailed in the provided context.

What other types of research exist?

Promising, novel alternatives to the NEUROMARK System for chronic rhinitis patients include: 1) ClariFix, a cryotherapy device that targets the posterior nasal nerve to reduce inflammation and symptoms. 2) RhinAer, a radiofrequency ablation device that also targets the posterior nasal nerve to alleviate symptoms. Both therapies focus on neuromodulation and have shown positive outcomes in clinical studies.

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NEUROMARK System for Chronic Rhinitis

N/A

Recruiting

Research Sponsored by Neurent Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have moderate to severe symptoms of running nose (individual rTNSS symptom rating of 2 or 3), mild to severe symptoms of nasal congestion (individual rTNSS symptom rating of 1, 2, or 3), and a minimum total score of 5 (out of 12) at screening

Be ≥18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the NEUROMARK System, a device for treating people with chronic rhinitis. It aims to see how well the device works in real-world settings by calming overactive nasal passages to reduce symptoms.

Who is the study for?

This trial is for adults over 18 with chronic rhinitis who are about to receive the NEUROMARK System treatment. Participants should have moderate to severe runny nose and mild to severe nasal congestion, scoring at least 5 out of 12 on a symptom scale. They must consent and follow study procedures.

What is being tested?

The NEUROMARK Registry Study is evaluating the real-world use of the NEUROMARK System in treating chronic rhinitis. It's an observational study collecting data from multiple centers on how well this system works after it has been sold.

What are the potential side effects?

While specific side effects aren't listed here, patients with a history of frequent or significant nosebleeds requiring medical help, especially within the last three months, cannot participate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a runny nose and nasal congestion with a symptom score of at least 5 out of 12.

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I am 18 years old or older.

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I am scheduled for treatment with the NEUROMARK System as recommended.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy - reflective Total Nasal Symptom Score (rTNSS)

Safety - incidence of device- and/or procedure-related serious adverse

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: NEUROMARK TreatmentExperimental Treatment1 Intervention

Interventional registry to collect real world data - Subjects will undergo treatment with the NEUROMARK System.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NEUROMARK System

2022

N/A

~40

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Neuromodulation treatments for chronic rhinitis, such as those being studied in the NEUROMARK System trial, work by targeting specific nerves involved in the inflammatory response of the nasal mucosa. By modulating the activity of these nerves, these treatments can reduce inflammation and improve nasal airflow, providing significant symptom relief. This approach is crucial for chronic rhinitis patients as it offers a non-pharmacological option that can alleviate persistent symptoms without the side effects associated with long-term medication use.