Abnormal Head Position and Neck Pain for These 7 Muscle Groups: Splenius,Scalene,Sterno-cleido-mastoid,Levator Scapulae,Semispinalis,Trapezius,and Longissimus. Clinical Trial
Official title:
ASIS for Botox in Cervical Dystonia
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 Cervical Dystonia. Gadolinium will be injected with ASIS subdermally (30) or
conventional intramuscularly (30) for these 7 muscle groups: Splenius, Scalene,
Sterno-cleido-mastoid, Levator scapulae, Semispinalis, Trapezius, and Longissimus. 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 Cervical Dystonia, and these particular 7 muscle
groups. Case in point, patients with Cervical Dystonia presumably have hyperactive Splenius,
Scalene, Sterno-cleido-mastoid, Levator scapulae, Semispinalis, Trapezius, and Longissimus
muscles, so expectantly will have shortened Gadolinium intramuscularly Persistent %, and
somewhat reduced Gadolinium subdermally Persistent % as well due to agitation, thus these
Persistent % values in Cervical Dystonia patients will not be like those of normal patients,
or even the same between these 7 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 Botox dosage and
duration to inject into "unknown" subdermal bloodless space for Aim 2.
Aim 2 over 12 months, using Botox, instead of Gadolinium, will demonstrate the advantages of
ASIS device subdermally over intramuscularly, for the same 60 adult subjects with Cervical
Dystonia, on these particular 7 muscle groups: Splenius, Scalene, Sterno-cleido-mastoid,
Levator scapulae, Semispinalis, Trapezius, and Longissimus. Hypothetically speaking, if that
subdermal bloodless space in patients with e.g., Cervical Dystonia 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 improvement on the
Physician Global Assessment Scale at 6, 12, 18, 24, and 30 weeks, and reduction in Cervical
Dystonia Severity Scale (CDSS) as well as 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