nVNS for the Prevention and Treatment of Primary Headache

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Feb 17, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called non-invasive vagus nerve stimulation (nVNS) for children and adolescents aged 7 to 20 who suffer from primary headaches, including migraines, cluster headaches, and tension-type headaches. The goal is to see if nVNS can help reduce headache pain both during an acute attack and as a preventive measure. Participants will be randomly assigned to one of two groups: one that receives treatment during a headache episode and another that receives preventive treatment. The effectiveness of the treatment will be measured by looking at changes in headache scores before and after using the nVNS device.

To be eligible for this trial, participants should have been diagnosed with a primary headache condition and experience headaches 3 to 15 days each month. They should also be stable on their current medications and not take any new medications during the trial. However, certain individuals, such as those with a history of severe headaches from other causes, certain medical conditions, or those using specific devices, will not be eligible to participate. If you or your child are considering taking part in this study, you can expect close monitoring during the treatment sessions and a chance to help researchers learn more about managing headaches in young people.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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 treatment of cluster headache (2022 edition).
• • 2. Age \>=7 years old, \<=20 years old;
• • 3. Patients have experienced headache on 3-15 days per month in the past;
• • 4. Maintain a stable dose and frequency of medication and do not take new drugs during the course of participating in the trial;
• • 5. They volunteered to participate in the trial and signed informed consent.
• Exclusion Criteria:
• • 1. History of secondary headache, aneurysm, intracranial hemorrhage, brain tumor, severe head trauma, drug abuse, addiction, syncope, or seizures;
• • 2. prior migraine-preventive surgery, cervical vagotomy, or implantation of an electronic or neurostimulator device;
• • 3. Simultaneous use of other devices (e.g., TENS devices, muscle stimulators);
• • 4. An implantable medical device in use, such as a pacemaker, hearing aid, or any implantable electronic device;
• • 5. underwent head and neck nerve block within the past 2 months;
• • 6. 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);
• • 7. Patients who underwent cervical vagotomy (cervical vagotomy);
• • 8. Pediatric patients (under 6 years old); Pregnant women;
• • 9. Patients with clinically significant hypertension, hypotension, bradycardia or tachycardia;
• • 10. Patients with congenital heart disease;
• • 11. Mental/cognitive disorders, etc.