ASIS for Botox in Upper Limb Spasticity

• Status: Unknown status
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: li nguyen
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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