Study Evaluating Treatment of Upper Limb Spasticity Using the Cryo-Touch III Device
A proof of concept study to evaluate the feasibility of safe and effective treatment of upper limb spasticity using the Cryo-Touch III Device.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment With the Cryo-Touch III Device for Upper Limb Spasticity|
- Improvement of hypertonia of the upper arm [ Time Frame: 7 days ] [ Designated as safety issue: No ]Improvement of hypertonia of the upper arm as measured by the Modified Ashworth Scale at Day 7.
- Safety Endpoints [ Time Frame: 56 Days ] [ Designated as safety issue: Yes ]Adverse events, serious adverse events (SAE) and unanticipated adverse device effects (UADE) will be assessed at all visits. Incidence of SAEs and UADEs will be recorded. A serious adverse event is one that meets the ISO definition of SAE.
- Improvement in spasticity [ Time Frame: 7 days ] [ Designated as safety issue: No ]Improvement in spasticity as measured by the Tardieu Scale.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
|Experimental: Treatment with the Cryo-Touch III Device||Device: Treatment with Cryo-Touch III device|
Spasticity, common in neurological disorders, is part of the upper motor neuron syndrome displaying increased tone, clonus, spasms, spastic dystonia and co- contractions. The impact of spasticity on the patient varies from a subtle neurological sign to severe spasticity causing pain and contractures. Upper limb spasticity (ULS) is the rapid contraction or shortening of the muscles in the arm causing abnormal muscle movements in the elbow, wrist and fingers. It has been reported that over 1 million Americans with traumatic injury to the brain or spinal cord, stroke, multiple sclerosis and cerebral palsy experience ULS. Tightly clenched fists, twisted wrist and elbow joints, and fixed arms in flexed positions result in extreme discomfort, pain and spasm. A nonsurgical, minimally invasive, effective approach to pain associated with ULS is desirable.
Myoscience, Inc. (Redwood City, CA) has developed a pain management device - the Cryo-Touch III - for a novel, minimally invasive procedure using focused cold therapy to target sensory nerve tissue and offer long-lasting pain relief through cryoanalgesia. The device operates on the well-established cryobiology principle that localized exposure to controlled, moderately low temperature conditions can alter tissue function. The therapy treats nerves via a probe in the form of an assembly of small diameter needles, creating a highly localized, low temperature treatment zone around the probe. This focused cold therapy creates a conduction block that prevents nerve signaling. Prior studies of the Cryo-Touch, Cryo-Touch II, Cryo-Touch III (a.k.a. PCP 1.0) devices have provided preliminary evidence of effectiveness on motor nerves and have been shown to be safe with no serious device-related adverse events.
|Contact: Sally Hallas, RN, BSNemail@example.com|
|Contact: Barbara Kovach, RNfirstname.lastname@example.org|
|United States, Kansas|
|Kansas City Bone and Joint Clinic||Recruiting|
|Overland Park, Kansas, United States, 66211|
|Contact: Nai-Ying Wesley email@example.com|
|Principal Investigator: Atul T Patel, M.D.|
|United States, Pennsylvania|
|Dr. Mitchell Paulin||Active, not recruiting|
|Paoli, Pennsylvania, United States, 19301|