AVPI Migraine Study

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Migraine

In brief

The study is designed as a multicenter, double-blind, randomized, sham-controlled trial to assess the safety and effectiveness of the Nocira AVPI Device for the acute treatment of migraine. The study is conducted in two phases in two study groups: * Phase I - initial screening of device operation in both active and sham modes in-clinic and as proctored by the investigator, and * Phase II - for further evaluation when used in the home (non-clinical) environment.

Key facts

Study ID

NCT05537818

Run by

Nocira, LLC

People needed

80

Starts

2022-06-30

Expected to finish

2024-01-31

Last updated by the study team

2023-05-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-75 years of age, inclusive, with at least a one-year history of migraine consistent with the ICHD-3 criteria
• Migraine onset before the age of 50 years
• Migraine attack frequency of 2-10 attacks per month with no more than 20 headache days per month on average over the last 3 months
• Willingness, ability, and commitment to participate in baseline and follow-up evaluations without concurrent participation in another clinical trial.
• Signed subject informed consent form.
• Typical untreated migraines are historically at least moderate to severe, by patient report.
• Subjects on prophylactic migraine medication must have been on a stable dose for at least 3 months prior to study entry and must remain on the same therapy with stable dosing during the study.
• Subjects must have wireless access to the internet via mobile computing or smartphone device for audio and/or video contacts

You may not qualify if…

• Failure to meet any of the inclusion criteria.
• Unwilling or unable to provide informed consent.
• Pregnancy or intent to become pregnant over the course of the study.
• Inability to distinguish migraine from other primary headache phenotypes.
• Presence of any condition or state that would prevent the subject from sitting or lying down comfortably during the course of the treatment (up to at least 30 minutes).
• Unable or unlikely to follow instructions for proper use of the device including connection of the phone to a wireless connection.
• Personal or family affiliation as a service provider - e.g., employee, contractor, consultant, or volunteer (other than as a subject in a previous clinical trial) - with a migraine treatment device company.
• Subjects with vital sign values that are outside acceptable norms.
• Systolic blood pressure > 160 mmHg
• Diastolic blood pressure > 100mmHg
• Resting heart rate >100 beats per minute
• Temperature > 100.5°F
• History of significant vestibular, auditory or external ear diagnoses or symptoms, including but not limited to Meniere's disease; endolymphatic hydrops; complete loss of hearing in either ear, significant hearing loss in either ear that requires a hearing aid or has deteriorated noticeably over the past year; previous ear surgery (including tympanostomy tubes); superior canal dehiscence, current or ongoing dizziness or vertigo, perforated or compromised tympanic membrane, external auditory canal obstruction which cannot be removed prior to treatment
• Current diagnosis or significant prior diagnosis of secondary headache (except MOH headache), cerebral aneurysm, intracranial hemorrhage, brain tumor, chiari malformation, or currently active occipital neuralgia that in the investigator's opinion would interfere with study-related assessments.
• Recent or current diagnoses of post-concussion syndrome, significant head trauma, substance abuse, addiction, syncope, or epilepsy, that in that the investigator's opinion would interfere in the assessments.
• Another significant pain disorder that in the investigator's opinion would interfere with study-related assessments.
• Any other information about the subject's medical condition that, in the reasonable professional judgement of the Investigator, may adversely affect the intended performance or safety of the study device, or that would confound understanding of the subjects' response to treatment with the device.
• Subjects who have been diagnosed with and/or being treated for currently active chronic neck pain conditions including, but not limited to, failed neck surgery, discogenic pain, radiculopathy, or whiplash.
• Psychiatric or cognitive disorders that in the investigator's opinion would interfere with the conduct of the study
• Unstable medical conditions which in the investigator's opinion could impede or preclude successful participation in the study, cause significant risk of serious adverse events in the study, or limit the subject's ability to complete study related treatments or assessments.
• MEDICATIONS \& MIGRAINE TREATMENTS
• Change in migraine preventive therapies or dosage within the preceding 3 months of Baseline Visit OR at any point during the study.
• Head or neck nerve block injections in the past 2 months.
• Post-COVID-19 patients with new presentations of dysautonomia, cognitive sensory changes, and imbalance presenting complaints which would limit the subject's ability to accurately and reliably identify and assess migraine pain, in the investigator's opinion.
• Previous use of pressure therapy or surgery in the ear for headache or any other condition (excluding diagnostic ear insufflation). Subjects enrolling in Group Ib will have participated in the NC05 study and will be allowed to enter as an exception to this criterion.

Where it is running

• ReGen Pain & Wellness — Scottsdale, Arizona, United States (enrolling)
• StudyMetrix — Saint Charles, Missouri, United States (enrolling)
• ClinVest — Springfield, Missouri, United States

Full record on ClinicalTrials.gov

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