Increased Muscle Tone in Elbow, Wrist, Finger, and Thumb Flexors. Clinical Trial
Official title:
ASIS for Botox in Upper Limb Spasticity
Botox act 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 Upper limb Spasticity. Gadolinium will be injected with ASIS subdermally (30)
or conventional intramuscularly (30) for these 7 muscle groups: Biceps Brachii, Flexor Carpi
Radialis, Flexor Carpi Ulnaris, Flexor Digitorum Profundus, Flexor Digitorum Sublimis,
Adductor Pollicis, and Flexor Pollicis Longus. 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 Upper limb Spasticity, and these particular 7 muscle groups. Case in point,
patients with Upper limb Spasticity presumably have hyperactivity in these 7 muscle groups,
so expectantly will have shortened Gadolinium intramuscularly Persistent %, and somewhat
reduced Gadolinium subdermally Persistent % as well due to agitation, thus these Persistent
% values in Upper limb Spasticity 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 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 same 60 adult subjects with Upper limb
Spasticity, on these particular 7 muscle groups: Biceps Brachii, Flexor Carpi Radialis,
Flexor Carpi Ulnaris, Flexor Digitorum Profundus, Flexor Digitorum Sublimis, Adductor
Pollicis, and Flexor Pollicis Longus. Hypothetically speaking, if that subdermal bloodless
space in patients with e.g., Upper limb Spasticity 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 and Ashworth score (force required to move an extremity around a joint), at
6,12,18,24, and 30 weeks, and reduction in 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