Treatment of Chronic Migraine Headaches.
Treatment of Chronic Migraine Headaches.
The purpose of the study is assessment of the safety and efficacy of the De-Novo therapy in
 the treatment of craniofacial neuralgia and migraine headaches.This is an open-label study of
 simultaneous administration of combination of dexamethasone, lidocaine, and thiamine into the
 trigeminal nerve branches as well as greater and lesser occipital nerve bilaterally in one
 session.

 Patients who meet the exclusion and inclusion criteria are eligible for trial if they have
 experienced chronic migraine and craniofacial pain not responding to other prior therapies.
A combination of dexamethasone, lidocaine and thiamine (pat.), may bring changes in the
 pattern of sympathetic and parasympathetic nerve signaling at the level vasa nervorum. These
 changes may down-regulate the hyperexcitable sympathetic signals at the level of adventitia
 and consequently the medial layer of vasa nervorum and providing long term relief from
 migraine headaches. However, a bilateral and simultaneous treatment of trigeminal and
 occipital nerves in migraine and craniofacial neuralgia using a combination of dexamethasone,
 thiamine and lidocaine has been rarely studied.

 The objective of this study is to assess the safety and efficacy of concomitant
 administration of dexamethasone, lidocaine, and thiamine compounds into the trigeminal nerve
 branches, the greater and lesser occipital nerve for the treatment of chronic migraine, and
 craniofacial neuralgia.
Inclusion Criteria:

 -  • Age: 10-90 years

 -  Ability to describe headache and its symptoms

 -  Ability to read, comprehend, and legibly and reliably record information

 -  Ability to provide written, informed consent, and respond to pre and post
 treatment questionnaires, children's guardian accepts responsibility. Willingness
 and ability to comply with the study scheduled visits, treatment plans,
 laboratory tests and other procedures

 -  Already diagnosed with chronic craniofacial neuralgia and chronic migraine
 headache

 -  Exhausted all or most of available abortive and preventive treatment modalities.

 Exclusion Criteria:

 -  • Uncontrollable hypertension, acute Myocardial Infarct within last 6 months

 -  History of cerebral vascular aneurysm/known atherosclerosis of cerebral system,
 brain tumor

 -  Implanted of neuro-stimulator, trigeminal tractotomy, neurectomy partial or
 complete, history of gamma knife treatment, microsurgical decompression
 procedure.

 -  Hypersensitivity or allergy to any components of De-Novo formula

 -  Presence or known anatomic craniofacial deformities or severe
 spondylosis/spondylolisthesis of cervical spine, profound dental caries,
 Maxillofacial deformities

 -  Pregnancy and current breast feeding status

 -  Headaches attribute to acute head and neck injuries, chronicity of cervicogenic
 headaches

 -  Skin infection or micro abscesses dermatogen or dental, ongoing treatment for
 Methicillin Resistant Streptococcus Aureus ( MRSA) unless treatment completed.