Treatment of Chronic Migraine Headaches. (Migraine)
Chronic Migraine Without Aura, Intractable, Migraine With Typical Aura, Migraine Disorders
About this trial
This is an interventional treatment trial for Chronic Migraine Without Aura, Intractable focused on measuring Migraine, Craniofacial Neuralgia
Eligibility Criteria
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.
Sites / Locations
- Corona Doctors Medical Clinics IncRecruiting
Arms of the Study
Arm 1
Experimental
Dexamethasone,Lidocaine,Thiamine cohort
Simultaneous administration of a combination of sterile dexamethasone phosphate total dose (bilaterally) of 20 mg, 4 mg/ml, Lidocaine Hydrochloride 1% 40 mg, 10 mg/ml, and Thiamine Hydrochloride 100 mg, 100 mg/ml in a single session into the accessible branches of the trigeminal nerve of the first, second, and third divisions, as well as into the greater and lesser occipital nerve. In first,patient placed in supine position then in prone position for comfortable access to injection site. De-Novo Treatment medication 'Dexamethasone, Lidocaine, Thiamine Cohort' prepared in single 1 milliliter volume sterile syringes, using 27 Gauge-30 Gauge needles.