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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately post treatment of 20-40 minutes
Awards & highlights
No Placebo-Only Group
Summary
This trial tests the Nocira AVPI Device, a gadget for quick migraine relief, on people who suffer from migraines. The device aims to reduce or stop migraine pain through a specific type of treatment.
Who is the study for?
Adults aged 18-75 with a history of migraines, experiencing 2-10 attacks per month. Participants must not be in other trials, should have stable migraine medication for 3 months if applicable, and need internet access via mobile device. Excluded are pregnant individuals, those unable to distinguish migraine types or follow instructions, with certain ear conditions or significant medical issues that could affect the study.
What is being tested?
The AVPI Device is being tested for its effectiveness in treating acute migraines. The trial has two phases: an initial screening (Phase I) where the device's operation is checked under supervision and a home-use evaluation (Phase II). It's a double-blind study meaning neither participants nor researchers know who gets the real treatment versus a sham (fake) one.
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include discomfort from wearing the device or reactions related to incorrect use. As it's non-invasive and doesn't involve drugs, traditional medication side effects are unlikely.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately post treatment of 20-40 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately post treatment of 20-40 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Headache Pain Freedom
Secondary study objectives
Freedom from the most bothersome symptom (MBS)
Functional compromise freedom
Overall satisfaction
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Group 2 Home TreatmentExperimental Treatment1 Intervention
Randomized active or sham for first home treatment followed by open-label treatments in the home environment.
Group II: Group 1b Clinic & Home TreatmentExperimental Treatment1 Intervention
Open-label, active treatment for subjects treated in prior clinical trials for this device, followed by open-label treatments in the home environment.
Group III: Group 1a Clinic TreatmentExperimental Treatment1 Intervention
Randomized, active or sham in-clinic treatment during a migraine, followed by open-label treatments in the home environment.
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
Common migraine treatments work through various mechanisms to alleviate symptoms. Pharmacological treatments like triptans activate serotonin receptors to reduce inflammation and constrict blood vessels, directly addressing the migraine's pathophysiology.
Non-pharmacological treatments, such as the Nocira AVPI Device, use neuromodulation to alter pain pathways by stimulating nerves, which can reduce pain perception. Understanding these mechanisms helps patients and healthcare providers select the most effective treatment based on individual migraine triggers and symptoms, potentially improving outcomes and quality of life.
Pharmacological trials in migraine: it's time to reappraise where the headache is and what the pain is like.Migraine: current therapeutic targets and future avenues.Study protocol for a pragmatic randomised controlled trial in general practice investigating the effectiveness of acupuncture against migraine.
Pharmacological trials in migraine: it's time to reappraise where the headache is and what the pain is like.Migraine: current therapeutic targets and future avenues.Study protocol for a pragmatic randomised controlled trial in general practice investigating the effectiveness of acupuncture against migraine.
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Who is running the clinical trial?
Nocira, LLCLead Sponsor
1 Previous Clinical Trials
80 Total Patients Enrolled
1 Trials studying Migraine
80 Patients Enrolled for Migraine
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not able to tell if your headaches are migraines or other types of primary headaches.You have a condition that makes it hard for you to sit or lie down comfortably for at least 30 minutes during treatment.You have had significant ear or balance problems in the past, including conditions like Meniere's disease, significant hearing loss, or ongoing dizziness.You have a history of certain serious head conditions that could affect the study assessments.If you have a migraine, it must have been treated within 10 hours for Phase I or 6 hours for Phase II after it started. If you can't remember when your migraine started, you won't be able to join the study.You received migraine medicine through an IV in the past two weeks.You have received nerve block injections in your head or neck in the last 2 months.You have tried at least 3 different devices to treat your migraines, and they didn't work for you. This doesn't include if you had to stop using them because of side effects or intolerance.You have tried at least three different prescription medications for migraines, but they didn't help with your migraines. This doesn't include cases where you had to stop the medication because of side effects or other issues.You have used opioids or barbiturates for more than 4 days per month on average in the last 3 months before the study starts.You have taken medication for a sudden headache or migraine in the past 24 hours before the treatment.You have neck pain that is as intense as the headache pain.Your migraines are usually at least moderately severe when you haven't taken any medicine for them.You have another pain condition that could make it hard for the researchers to track your progress in the study.You are currently being treated for chronic neck pain, including conditions like failed neck surgery, discogenic pain, radiculopathy, or whiplash.If you recently had COVID-19 and are experiencing new problems with your body's automatic functions, thinking, senses, or balance that could make it hard for you to accurately tell us about your migraine pain.You have not had surgery or pressure therapy in your ear for headaches or other conditions, except for diagnostic ear insufflation. If you were part of the NC05 study, you can still participate even if you had previous ear treatments.You can't have another migraine within one day after your last one has ended.You have had an ear infection or another ear problem since joining the study.You have had recent or current diagnoses of head injury, substance abuse, or epilepsy that could affect the study assessments according to the investigator.If you have a migraine, it needs to be at least moderately painful for you to participate in the study. If the study allows open-label use, you can treat mild headaches.You have 2-10 migraines per month and no more than 20 headache days per month on average over the last 3 months.If you have a migraine attack, it won't be included in the study.You have used any medication or medical device to treat a migraine attack in the past.You are between 18 and 75 years old and have had migraines for at least one year that match certain medical criteria.You started getting migraines before you were 50 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1a Clinic Treatment
- Group 2: Group 1b Clinic & Home Treatment
- Group 3: Group 2 Home Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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