Clinical trial NCT02074150: ASIS for Botox in Upper Limb Spasticity
Official title: ASIS for Botox in Upper Limb Spasticity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Upper Limb Spasticity Unilaterally in Adults With History of Stroke
Increased Muscle Tone in Elbow, Wrist, Finger, and Thumb Flexors.
Keywords: Subdermal bloodless space
Subdermal injection
injectable EMG needle
electrical stimulation
MRI with Gadolinium
Upper Limb Spasticity
intramuscular injection
Lead sponsor: ASIS Corporation
Sponsor class: INDUSTRY
First posted: 2014-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Relative Prolongation Ability Score for Gadolinium subdermally injected.
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy of Botox intramuscularly vs. subdermally in Upper Limb Spasticity.
timeFrame: 12 months
Other outcomes:
measure: Adverse Reactions of Botox intramuscularly vs. subdermally in Upper Limb Spasticity
timeFrame: 12 months
Locations:
city: Westminster
country: United States
facility: Automatic Subdermal Injector System, Inc
state: California
Study officials:
affiliation: AUTOMATIC SUBDERMAL INJECTOR SYSTEM INC
name: Li Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AUTOMATIC SUBDERMAL INJECTOR SYSTEM, INC
name: Thanh Phung,, MD
role: PRINCIPAL_INVESTIGATOR
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