Clinical Investigational Plan (CIP) of Migraelief WearableDevice for the treatment of Migraine An open label single arm multicentre controlled study

BramhAnsh Technologies Pvt Ltd0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年5月27日

试验速览

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•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.

•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.

发起方

BramhAnsh Technologies Pvt Ltd