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临床试验/CTRI/2024/11/077261
CTRI/2024/11/077261已完成不适用

Effect Of Vagus Nerve Stimulation On Headache And Heart Rate Variability In Patients Of Chronic Migraine

Multidisciplinary Research Unit funded by Department of Health Research1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年12月3日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
1
主要终点
decrease in intensity , frequency and duration of headache with improvement in HIT6 score in 6 weeks

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

decrease in intensity , frequency and duration of headache with improvement in HIT6 score in 6 weeks

时间窗: decrease in intensity , frequency and duration of headache with improvement in HIT6 score in 6 weeks

次要结局

  • effect on Heart Rate Variability at 6 weeks(effect on Heart Rate Variability at 6 weeks)

研究者

发起方
Multidisciplinary Research Unit funded by Department of Health Research
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Samiksha Rana

ESIC Medical college and Hospital , Faridabad

研究点 (1)

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