BridgeMD
Prevention study for Primary Headache
Official title nVNS for the Prevention and Treatment of Primary Headache
ClinicalTrials.gov ID: NCT06277063
What this study is testing
- What it's testing
- This study is a single-center, single-arm study. All subjects will receive the same treatment.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 20
You may be able to join if
- Patients with migraine, cluster headache and tension-type headache were diagnosed according to Chinese Guidelines for the diagnosis and Treatment of...
- Age \>=7 years old, \<=20 years old;
- Patients have experienced headache on 3-15 days per month in the past;
- Maintain a stable dose and frequency of medication and do not take new drugs during the course of participating in the trial;
- They volunteered to participate in the trial and signed informed consent.
You likely can't join if
- History of secondary headache, aneurysm, intracranial hemorrhage, brain tumor, severe head trauma, drug abuse, addiction, syncope, or seizures;
- prior migraine-preventive surgery, cervical vagotomy, or implantation of an electronic or neurostimulator device;
- Simultaneous use of other devices (e.g., TENS devices, muscle stimulators);
- An implantable medical device in use, such as a pacemaker, hearing aid, or any implantable electronic device;
- underwent head and neck nerve block within the past 2 months;
- Opioid use (more than 2 days per month); Use of analgesics alone or non-steroidal anti-inflammatory drugs (more than 15 days per month); Or...
See the full eligibility criteria
- Patients with migraine, cluster headache and tension-type headache were diagnosed according to Chinese Guidelines for the diagnosis and Treatment of Migraine (2022 edition) and Chinese Guidelines for the diagnosis and...
- Age \>=7 years old, \<=20 years old;
- Patients have experienced headache on 3-15 days per month in the past;
- Maintain a stable dose and frequency of medication and do not take new drugs during the course of participating in the trial;
- They volunteered to participate in the trial and signed informed consent.
- History of secondary headache, aneurysm, intracranial hemorrhage, brain tumor, severe head trauma, drug abuse, addiction, syncope, or seizures;
- prior migraine-preventive surgery, cervical vagotomy, or implantation of an electronic or neurostimulator device;
- Simultaneous use of other devices (e.g., TENS devices, muscle stimulators);
- An implantable medical device in use, such as a pacemaker, hearing aid, or any implantable electronic device;
- underwent head and neck nerve block within the past 2 months;
- Opioid use (more than 2 days per month); Use of analgesics alone or non-steroidal anti-inflammatory drugs (more than 15 days per month); Or tamoxifen, ergots or combination analgesics (more than 10 days per month);
- Patients who underwent cervical vagotomy (cervical vagotomy);
- Pediatric patients (under 6 years old); Pregnant women;
- Patients with clinically significant hypertension, hypotension, bradycardia or tachycardia;
- Patients with congenital heart disease;
- Mental/cognitive disorders, etc.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 20 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.