Increased Muscle Tone in Elbow, Wrist, Finger, and Thumb Flexors. Clinical Trial
— ASISinULSOfficial 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.
| Status | Not yet recruiting |
| Enrollment | 60 |
| Est. completion date | June 2017 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Automatic Subdermal Injector System, Inc | Westminster | California |
| Lead Sponsor | Collaborator |
|---|---|
| li nguyen |
United States,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Adverse Reactions of Botox intramuscularly vs. subdermally in Upper Limb Spasticity | Adverse Reactions of Botox intramuscularly vs. subdermally: Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension. |
12 months | Yes |
| Primary | Relative Prolongation Ability Score for Gadolinium subdermally injected. | Gadolinium will be injected with ASIS subdermally (30) or intramuscularly (30) in Upper Limb Spasticity adult patients 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. MRI will be taken promptly after, as starting reference, to which subsequent MRI at 6 hrs, 12 hrs, and 24 hrs later will be compared for Persistent %. This approximation can only work if the variables are minimized to the same population with Upper Limb Spasticity, and these particular 7 muscle groups. The Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % intramuscularly, in Upper Limb Spasticity patients will not be same as normal patients, or even between these 7 different muscle groups, but valuable indicators to help us modify Botox dosage and duration to inject into "unknown" subdermal bloodless space for Aim 2. | 6 months | No |
| Secondary | Efficacy of Botox intramuscularly vs. subdermally in Upper Limb Spasticity. | Efficacy of Botox intramuscularly vs. subdermally with ASIS Device at Week 6,12,18, 24, and 30; in terms of improvement on the Physician Global Assessment Scale (-4=very marked worsening to +4=very marked improvement). Also in terms of improvement, or Median Change from Baseline in Flexor Tone on Ashworth Scale, for Elbow, Wrist, Finger, and Thumb. Ashworth score (the force required to move an extremity around a joint): 0 = No increase in muscle tone (none) = Slight increase in muscle tone, giving a 'catch' when the limb was flexed or extended (mild) = More marked increase in muscle tone but affected limb is easily flexed (moderate) = Considerable increase in muscle tone - passive movement difficult (severe) = Limb rigid in flexion or extension (very severe). |
12 months | Yes |