Chronic Migraine More than15 Days Per Month, and Lasting 4 Hours a Day or Longer. Clinical Trial
Official title:
ASIS for Botox in Chronic Migraine
Botox acts on nerve endings, yet there are no nerve endings inside the muscle, where they are typically injected. All nerves terminate on the fascia, where ASIS device can precisely deliver Botox by creating that subdermal bloodless space, between the skin and muscle. Thus enhancing and prolonging Botox's efficacy, at the same time prevent it's unnecessary adverse reactions and distant spread, especially since Botox has no reason to travel to the rest of the body any way.
Aim 1 over 6 months will demonstrate ASIS device's consistent performance on 60 adult
subjects with Chronic Migraine (≥15 days per month, with headache lasting 4 hours a day or
longer). Gadolinium will be injected with ASIS subdermally (30) or conventional
intramuscularly (30) for these 6 muscle groups: Glabella, Frontal, Temporal, Occipital,
Paraspinal, and Trapezius. An MRI will be taken promptly after Gadolinium injection, as
starting reference, to which subsequent MRI taken at 6 hrs, 12 hrs, and 24 hrs later will be
compared for Persistent %. Since there isn't a way to measure level of Gadolinium within it,
or any other (e.g. Botox) for that matter, at least the Prolongation of Gadolinium may be
approximated by the greater or longer Persistent % on MRI. However, this approximation can
only work if the variables are minimized to the same population with Chronic Migraine, and
these particular 6 muscle groups. Case in point, patients with Chronic Migraine presumably
have hyperactive Glabella, Frontal, Temporal, Occipital, Paraspinal, and Trapezius muscles,
so expectantly will have shortened Gadolinium intramuscularly Persistent %, and somewhat
Gadolinium subdermally Persistent % as well due to agitation, thus these Persistent % values
in Chronic Migraine patients will not be like those of normal patients, or even the same
between these 6 different muscle groups. Therefore, the Relative Prolongation Ability Score
or total Persistent % subdermally over total Persistent % intramuscularly, will be specific
and valuable indicators to help us modify the Botox dosage and duration to inject into that
"unknown" subdermal bloodless space for Aim 2.
Aim 2 over 12 months, using Botox, instead of Gadolinium, to demonstrate the advantages of
ASIS device subdermally over intramuscularly, for the particular 6 muscle groups on the same
60 Chronic Migraine adults. Given that there isn't a way to detect Botox in the peripheral
blood to document Prolongation of Botox Pharmacokinetically, this Relative Prolongation
Ability is our best and only possible way to demonstrate that subdermal bloodless space's
ability on Botox. Although valuable, that Relative Prolongation Ability Score from Aim 1
isn't absolutely required to start Aim 2. Hypothetically speaking, if that subdermal
bloodless space in patients with e.g., Chronic Migraine somehow failed to show prolongation
of half-life for Gadolinium in Aim 1, we can still proceed with primary interest being
therapeutic comparison for Botox in Aim 2, in terms of reduction in Number of Headache Days
from Baseline, and adverse reactions.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment