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Procedure

NEUROMARK System for Movement Disorders

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

Be ≥18 years of age

Have moderate to severe symptoms of runny 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 baseline

Must not have

Have had previous sinus or nasal surgery within 6 months of study enrollment

Have rhinitis symptoms that are due to seasonal allergies only

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90-days post procedure follow-up

Summary

This trial is researching a new treatment to help people with movement disorders.

Who is the study for?

This trial is for adults over 18 who've had a runny or stuffy nose from non-seasonal allergies for at least 6 months. They must be fit for the NEUROMARK treatment under local anesthesia and willing to follow the study's procedures. People with severe nasal structure issues, recent nasal surgery, or those treated before for rhinitis aren't eligible.

What is being tested?

The NEUROMARK RCT Study is testing a new system designed to treat chronic rhinitis symptoms against a sham (fake) procedure. Participants won't know which they receive in this controlled test where treatments are assigned randomly.

What are the potential side effects?

Possible side effects of the NEUROMARK System may include discomfort during treatment, temporary increase in nasal symptoms, bleeding, infection risk, and reactions to local anesthesia.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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

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I have had symptoms of a runny or blocked nose for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had sinus or nasal surgery less than 6 months ago.

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My runny nose and sneezing are caused by seasonal allergies.

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I have had surgery or treatments like RF or cryotherapy for my rhinitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90-days post procedure follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90-days post procedure follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90-days post procedure 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

rTNSS

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ActiveActive Control1 Intervention

Subjects in this arm will undergo treatment with the NEUROMARK device.

Group II: ShamPlacebo Group1 Intervention

Subjects in this arm will undergo the procedure with a Sham device. Sham control participants will be offered the option to receive active treatment after the 90-day follow-up provided they still meet all eligibility criteria.

0 / 6Eligibility criteria met