Effect Of Vagus Nerve Stimulation On Headache And Heart Rate Variability In Patients Of Chronic Migraine
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- decrease in intensity , frequency and duration of headache with improvement in HIT6 score in 6 weeks
Study Overview
Brief Summary
Migraine is a common and debilitating neurological disorder, often causing significant disability, particularly in young women. Chronic migraine (CM), defined as headaches occurring 15 or more days per month with migraine characteristics on at least 8 days, affects about 1-2% of the global population. Despite treatment options such as triptans and prophylactic therapies like beta-blockers and Onabotulinum toxin-A, treatment efficacy remains suboptimal, and many patients experience medication overuse headaches. This has led to interest in non-pharmacological treatments, such as transcutaneous auricular non-invasive vagus nerve stimulation (ta-nVNS), which has shown promise in reducing the frequency and severity of migraines.
The proposed study aims to assess the efficacy of ta-nVNS in both the prevention and management of chronic migraine, specifically focusing on headache frequency, duration, and heart rate variability (HRV), a marker of autonomic dysfunction associated with migraine. Patients diagnosed with chronic migraine will receive ta-nVNS treatment twice weekly for six weeks. The study will also record HRV as a secondary outcome to assess autonomic function changes. The findings could provide valuable insights into the role of ta-nVNS in migraine management, particularly in under-researched populations such as those in India.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •diagnosed case of chronic migraine without aura and on pharmacological prophylaxis for the past 3 months.
- •the patient should be able to provide informed consent for using the ta-VNS device and self-assessment scale.
Exclusion Criteria
- •History of Neurological disorder, cardiovascular disease, CVA, asthma, or any other co-morbidity that may cause sudden death.
- •The patient is known to have auricular trauma or surgery that may affect the application of the ta-VNS device.
- •Has uncontrolled high blood pressure, and a history of syncope or seizures.
- •It is currently implanted with an electrical or neuro-stimulatory device.
- •Has a history of substance abuse.
- •Is pregnant or planning conception in the next three months.
- •Is a participant in any other therapeutic clinical investigation or clinical trial in the preceding 30 days.
- •Has a condition that compromises his/her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments.
Outcomes
Primary Outcomes
decrease in intensity , frequency and duration of headache with improvement in HIT6 score in 6 weeks
Time Frame: decrease in intensity , frequency and duration of headache with improvement in HIT6 score in 6 weeks
Secondary Outcomes
- effect on Heart Rate Variability at 6 weeks(effect on Heart Rate Variability at 6 weeks)
Investigators
Dr Samiksha Rana
ESIC Medical college and Hospital , Faridabad