Health Condition 1: 4- Measurement and Monitoring
Conditions
Interventions
Intervention1: Migraelief Wearable Device: Migraelief is a wearable Neuromodulation device useful in reducing migraine headache pain intensity the device generates low frequency sound vibration waves
Sponsors
BramhAnsh Technologies Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects of either sex between 18 and 70 years of age. 2. Subjects complaining of migraine attacks at regular frequency, at least twice a month. 3. Subjects agreeing to use the device regularly 4. Subject signing informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subject suffering from any neurological disorder other than migraine. 2. Pregnant or lactating subjects 3. Habitual users of drugs of abuse or patients of psychiatric disorders 4. Patients suffering from carcinoma of any site 5. Patient suffering from any other disorder that in the opinion of the investigator make them unsuitable for the study. 6. History of severe head trauma brain surgery implants in the head or neck history of seizures. 7. Skin disorder or skin defects which compromise the integrity or sensitivity of the skin at or near locations where device will be applied. 8. Subjects with epilepsy seizure vertigo and brain injury in last 9 months 9. Concurrent use of Botox or calcitonin gene-related peptide (CGRP) monoclonal antibodies treatments 10. Unstable acute medical condition 11. Any serious malignant or non-malignant acute or chronic medical condition or active psychiatric illness that in the Investigators opinion, could compromise patient safety, limit the patients ability to complete the study and/or compromise the objectives of the study 12. Used any investigational drug, biologic, or device within 30 days prior to screening or 5 half-lives whichever is longer. 13. Taking opioid analgesics or barbiturates on more than 2 days a week 14. Taking medications acting as antagonist on the NmethylDaspartate (NMDA) receptor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the intensity of migraine headache and associated symptoms before and after the use of Migraelief Wearable DeviceTimepoint: 16 to 77 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the rescue drug dependency, frequency and duration of headache and associated symptoms of migraine during the use of Migraelief Wearable Device to those before initiation and usage of the device. To compare the incidence of photo and acoustic sensitivity during migraine attacks before and during or after the use of Migraelief Wearable Device. To compare Migraine quality of life with baseline toduring or after the use of device in trial period. To record adverse events, if any, associated with the use of Migraelief Wearable Device. Timepoint: 16 to 77 Days | — |
Countries
India
Contacts
Public ContactS Kumar
Bramhansh Technologies Pvt Ltd
Outcome results
None listed