Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623188
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Treatment of Episodic Migraine with AURICular Neuromodulation a Prospective Randomized Placebo-controlled Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Treatment of Episodic Migraine with AURICular Neuromodulation a Prospective Randomized Placebo-controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MENAURIC
Brief Summary:
Migraine is a ubiquitous pathology affecting approximately 1 billion individuals and being the leading cause of morbidity worldwide before the age of 50 Migraine treatment consists of two main approaches acute treatment to relieve headache symptoms and preventive treatment to reduce the frequency of migraine attacks by at least 50 Preventive treatment involves medications such as beta-blockers antiepileptics calcium channel blockers and a new therapeutic class called calcitonin gene-related peptide CGRP inhibitors While traditional treatments have modest efficacy and limited tolerability CGRP inhibitors have shown better tolerability and superior efficacy However their prescription in France is restricted to neurologists and specialized pain evaluation and treatment units Additionally the long-term effects of CGRP inhibition on blood pressure control and vascular homeostasis are not fully understood
In addition to pharmacological preventive treatment non-pharmacological approaches have emerged such as auricular neurostimulation This can be achieved through electrical stimulation of the cymba conchae considered a non-invasive alternative to invasive vagal stimulation and has shown benefits in reducing the number of migraine days compared to a placebo Another approach involves stimulation of specific areas of the entire auricle using techniques borrowed from auriculotherapy auricular acupuncture
The objective of the study is to demonstrate that auricular neuromodulation performed with a laser device targeted and personalized on selected areas of the auricle has a beneficial effect on the number of moderate to severe migraine days per month
In addition to pharmacological preventive treatment non-pharmacological approaches have emerged such as auricular neurostimulation This can be achieved through electrical stimulation of the cymba conchae considered a non-invasive alternative to invasive vagal stimulation and has shown benefits in reducing the number of migraine days compared to a placebo Another approach involves stimulation of specific areas of the entire auricle using techniques borrowed from auriculotherapy auricular acupuncture
The objective of the study is to demonstrate that auricular neuromodulation performed with a laser device targeted and personalized on selected areas of the auricle has a beneficial effect on the number of moderate to severe migraine days per month
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None