ASIS for Botox in Cervical Dystonia

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

Summary

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.

• 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 cervical dystonia, or abnormal head position and neck pain for these 7 muscle groups: Splenius, Scalene, Sterno-cleido-mastoid, Levator scapulae, Semispinalis, Trapezius, and Longissimus.

Exclusion Criteria:

• Known Hypersensitivity to Botulinum Toxin or to any of the components in the formulation.

• Infection at the Injection Site(s).

• Has any medical condition that may increase their risk with exposure to Botox including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.

• Has profound atrophy or weakness of muscles in the target areas of injection.

• Had previously received surgical or other denervation treatment for their symptoms or had a known history of neuromuscular disorder.