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NC06 Trial Summary
This trial tests the safety and effectiveness of a device for treating migraines in two stages: an in-clinic evaluation and home use.
NC06 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNC06 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.NC06 Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Group 1a Clinic Treatment
- Group 2: Group 1b Clinic & Home Treatment
- Group 3: Group 2 Home Treatment
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Are there any available slots that participants can enroll in for this experiment?
"Affirmative. According to clinicaltrials.gov, this clinical trial is presently searching for contenders. It was initially published on June 30th 2022 and recently amended on November 25th of the same year. 80 patients need to be gathered from 3 distinct sites."
Are members of the geriatric population being included in this trial?
"The enrollment qualifications for this medical research stipulate that the minimum age requirement is 18 and the maximum upper limit of eligibility is 75."
How many people are participating in this clinical experiment?
"Affirmative. According to the information hosted on clinicaltrials.gov, this trial initiated in June 2022 and is actively recruiting patients at present. 80 participants are needed from 3 medical facilities for it to move forward properly."
May I apply to participate in this research trial?
"This trial is enrolling 80 persons aged eighteen to seventy-five afflicted by migraines. Candidates must meet the following considerations: having signed an informed consent form, access to a wireless internet connection, 1 year history of migraine symptoms congruent with ICHD-3 criteria prior to age fifty, willingness and capacity for taking part in baseline and follow up evaluations without concurrent participation in another clinical trial, self reported moderate or severe episodes at least two times per month on average over three months preceding study entry; prophylactic medication users need have been using stable doses for no less than 3 months preceeding enrolment and remain"
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