Health Condition 1: G437- Chronic migraine without aura
Conditions
Interventions
Intervention1: transcutaneous auricular non-invasive Vagus nerve stimulation: transcutaneous auricular non-invasive Vagus nerve stimulation device from Soterix Medical hand-held Electrical Stimulation
Sponsors
Multidisciplinary Research Unit funded by Department of Health Research
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| decrease in intensity , frequency and duration of headache with improvement in HIT6 score in 6 weeksTimepoint: decrease in intensity , frequency and duration of headache with improvement in HIT6 score in 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| effect on Heart Rate Variability at 6 weeksTimepoint: effect on Heart Rate Variability at 6 weeks | — |
Countries
India
Contacts
Public ContactDr Samiksha Rana
ESIC Medical college and Hospital , Faridabad
Outcome results
None listed