ASIS for Botox in Cervical Dystonia
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Neurology, Orthopedic, Pain |
| Therapuetic Areas: | Musculoskeletal, Neurology, Orthopedics / Podiatry |
| 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 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.
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.
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.
Inclusion Criteria:
•Adults with cervical dystonia, or abnormal head position and neck pain for these 7 muscle
groups: Splenius, Scalene, Sterno-cleido-mastoid, Levator scapulae, Semispinalis,
Trapezius, and Longissimus.
Exclusion Criteria:
- Known Hypersensitivity to Botulinum Toxin or to any of the components in the
formulation.
- Infection at the Injection Site(s).
- Has any medical condition that may increase their risk with exposure to Botox
including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral
sclerosis, or any other significant disease that might interfere with neuromuscular
function.
- Has profound atrophy or weakness of muscles in the target areas of injection.
- Had previously received surgical or other denervation treatment for their symptoms or
had a known history of neuromuscular disorder.
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