ASIS for Botox in Upper Limb Spasticity
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | January 2016 |
| End Date: | June 2017 |
| Contact: | Li Nguyen, MD |
| Email: | dr.li.nguyen@asis-inc.com |
| Phone: | (714)-453-7857 |
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.
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.
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.
Inclusion Criteria:
- Adults with history of stroke that resulted in a unilateral, upper-limb focal
spasticity
- Wrist flexor tone of more than 2 and finger flexor tone of more than 2 as measured by
the Ashworth Scale
- Ability to understand and follow verbal directions
- At least 1 functional disability item (hygiene, dressing, pain, or limb posture) with
a rating of more than 2 on the Disability Assessment Scale (DAS)
- At least 1 functional task score at Day 0 that met the following criteria: nail
filing less than 6, hand cleaning less than 6, holding a water bottle less than 4,
brushing teeth less than 4, holding fruit (small, medium, or large equals no.
Exclusion Criteria:
- Stroke within 6 months of the study enrollment visit
- Females who are pregnant, nursing, or planning a pregnancy during the study period or
who are not using a reliable means of contraception
- Previous or current Botox therapy of any type in the study limb
- Any medical condition that may put the patient at increased risk with Botox exposure
or any other disorder that might have interfered with neuromuscular function
- Presence of fixed contracture of the study limb
- Limited use of the wrist and fingers
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