Clinical Exploration of NEUROMARK System in Participants With Chronic Migraine

NCT06862674 | Completed FDA Device

• 1 other identifier: CIP-0011
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 7

Brief Summary

Clinical exploration of NEUROMARK System in Participants with Chronic Migraine

Conditions

Chronic Migraine Headache

Outcome Measures

Primary Outcomes (1)

• Mean Change from Baseline in Monthly Migraine Headache Days

  Monthly headache logs were used to record headache frequency, intensity, duration, and pain. Mean change from baseline in number of migraine headache days per month was assessed over 6 months.

  6 months

Other Outcomes (3)

• Mean Change from Baseline in Sino-Nasal Outcome Test (SNOT-22) Total Score

  6 months

• Mean Change from Baseline in Migraine-Specific Quality of Life Questionnaire (MSQ) Score

  6 months

• Mean Change from Baseline in Headache Impact Test-6 (HIT-6) Total Score

  6 months

Study Arms (1)

Single-arm Treatment

EXPERIMENTAL

Participants that provide informed consent and meet study eligibility requirements will receive treatment. Participants will have the NEUROMARK System applied to both nostrils during a single session.

Device: NEUROMARK System

Interventions

NEUROMARK System DEVICE

NEUROMARK System for Chronic Migraine

Single-arm Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant Must:
• Be ≥18 years of age.
• Have Chronic Migraine
• Be willing and able to comply with all study elements, as indicated by written informed consent.

You may not qualify if:

• Participant Must Not:
• Have diagnosis or history of complicated migraine, basilar migraine, ophthalmoplegic migraine, hemiplegic migraine, or migrainous infarction.
• Progressive neurologic disorder other than migraine.
• Have clinically significant anatomic obstruction that in the investigator's opinion limit access to the posterior nose, including but not limited to severe septal deviation or perforation, nasal polyps, and/or sinonasal tumor.
• Have plans to (or otherwise anticipates the need to) undergo an ENT procedure concurrently or during study.
• Have had previous sinus or nasal surgery within 6 months of study enrollment.
• Have previously undergone radiofrequency, cryotherapy, or other surgical interventions for rhinitis.
• Have started a new migraine medication regimen within 3 months of study enrollment that, according to the manufacturer's labeling, has not yet stabilized.
• Have an acute nasal or sinus infection.
• Have nasal mucosal erosion/ulceration.
• Be on prescribed anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be held for an appropriate time before the procedure.
• Have hemophilia.
• Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
• Have numbness of the soft palate, excessive dry eye, excessive dry nose, or other indication of neuro/nerve compromise in the sinonasal cavity.
• Have had previous head and/or neck irradiation.

Sponsors & Collaborators

• Neurent Medical: lead

Study Sites (7)

ExcelENT

Birmingham, Alabama, 36801, United States

Location

East Alabama ENT

Opelika, Alabama, 36801, United States

Location

Sensa Health

Los Angeles, California, 90006, United States

Location

Sacramento ENT

Sacramento, California, 95661, United States

Location

Senta Clinic

San Diego, California, 92108, United States

Location

Ascension St. Vincent

Anderson, Indiana, 46016, United States

Location

Specialty Physician Associates

Bethlehem, Pennsylvania, 18017, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: March 6, 2025
• Study Start: September 6, 2024
• Primary Completion: January 21, 2026
• Study Completion: January 21, 2026
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)