Study Evaluating Treatment of Upper Limb Spasticity Using the Cryo-Touch III Device
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|ClinicalTrials.gov Identifier: NCT01863901|
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : April 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Upper Limb Spasticity||Device: Treatment with Cryo-Touch III device||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment With the Cryo-Touch III Device for Upper Limb Spasticity|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||October 2013|
|Experimental: Treatment with the Cryo-Touch III Device||
Device: Treatment with Cryo-Touch III device
- Improvement of hypertonia of the upper arm [ Time Frame: 7 days ]Improvement of hypertonia of the upper arm as measured by the Modified Ashworth Scale at Day 7.
- Safety Endpoints [ Time Frame: 56 Days ]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 ]Improvement in spasticity as measured by the Tardieu Scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01863901
|United States, Kansas|
|Kansas City Bone and Joint Clinic|
|Overland Park, Kansas, United States, 66211|
|United States, Pennsylvania|
|Dr. Mitchell Paulin|
|Paoli, Pennsylvania, United States, 19301|