ASIS for Botox in Cervical Dystonia (ASISinCD)

NCT02074293 Phase 1/Phase 2 UNKNOWN

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.

Details

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

Conditions

• Cervical Dystonia Adults ,
• Abnormal Head Position and Neck Pain for These 7 Muscle Groups: Splenius,Scalene,Sterno-cleido-mastoid,Levator Scapulae,Semispinalis,Trapezius,and Longissimus.

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 conventional intramuscularly (30) in Cervical Dystonia adult patients 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 %. This approximation can only work if the variables are minimized to the same population with Cervical Dystonia, and these particular 7 muscle groups. The Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % intramuscularly, in Cervical Dystonia patients will not be like those of normal patients, or even the same 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