ASIS for Botox in Upper Limb Spasticity (ASISinULS)

NCT02074150 Phase 1/Phase 2 UNKNOWN

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.

Details

Lead sponsor	li nguyen
Phase	Phase 1/Phase 2
Status	UNKNOWN
Enrolment	60
Start date	2016-01
Completion	2017-06

Conditions

• Upper Limb Spasticity Unilaterally in Adults With History of Stroke
• Increased Muscle Tone in Elbow, Wrist, Finger, and Thumb Flexors.

Interventions

• Gadolinium
• Gadolinium
• Gadolinium
• Efficacy of Botox intramuscularly at Week 6
• Efficacy of Botox intramuscularly at Week 12,
• Efficacy of Botox intramuscularly at Week 18
• Efficacy of Botox intramuscularly at Week 24
• Efficacy of Botox intramuscularly at Week 30
• Efficacy of Botox subdermally at Week 6
• Efficacy of Botox subdermally at Week 12

Primary outcomes

• Relative Prolongation Ability Score for Gadolinium subdermally injected. — 6 months
  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.

Countries

United States