Study Evaluating Treatment of Upper Limb Spasticity Using the Cryo-Touch III Device

Study Overview
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Brief Summary
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A proof of concept study to evaluate the feasibility of safe and effective treatment of upper limb spasticity using the Cryo-Touch III Device.

Detailed Description
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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.

Official Title
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A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment With the Cryo-Touch III Device for Upper Limb Spasticity

Conditions
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Upper Limb Spasticity

Intervention / Treatment
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* Device: Treatment with Cryo-Touch III device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18 years of age and older. Trial participants must have a confirmed diagnosis that results in spasticity involving muscle innervated by the musculocutaneous nerve (MCN). Any medications must be maintained on a stable schedule for at least two weeks prior to treatment. No washout period is allowed. Must have an average score on the Modified Ashworth Scale for Spasticity of ≥ 2 over the last 30 days in the elbow. Subject, in the Investigator's opinion, will not be exposed to unacceptable risk by participation. Exclusion Criteria: Previous surgical intervention that altered the target neural anatomy of the upper limb. Any injection (neurolytic, sclerosing, anesthetic, etc.) to the upper limb within the last 4 months. Current enrollment in an investigational drug or device study that specifically targets spasticity management. Allergy or intolerance to local anesthesia. Any local skin condition at the treatment site that in the investigator's opinion would adversely affect treatment or outcomes. Any chronic medication use (prescription, over-the-counter, etc.) that in the investigator's opinion would affect study participation or subject safety. Diagnosis of cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, open and/or infected wounds. Diagnosis of progressive neurologic diseases such as ALS. For any reason, in the opinion of the investigator, the subject may not be a suitable candidate for study participation (i.e., history of noncompliance, drug dependency, any related upper limb injury, etc.).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with the Cryo-Touch III Device<br> | Device: Treatment with Cryo-Touch III device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Pain and Symptoms Caused by Hypertonia in the Upper Arm as Measured by an Improvement of 1 Point or Greater on the Modified Ashworth Scale (MAS) at Day 7 | The Modified Ashworth Scale (MAS) is 6-point scale designed to assess muscle tone and spasticity through the flexion or extension of a joint. Muscle response is graded on a scale from 0 (no increase in muscle tone) to 4 (affected parts rigid in flexion or extension). This includes a 1+ rating, which further distinguishes the types of increase in muscle tone from those described by a 1 or 2 rating. | Baseline to: post-treatment (Day 0), Day 7, Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Spasticity as Measured by the Tardieu Scale | The Tardieu Scale uses the application of stretch at several velocities to quantify muscle response and assess muscle spasticity. Two specified velocities were assessed (V1 and V2). For each stretch, quality of muscle reaction (X) is recorded on a 6-point scale from 0 (no resistance throughout passive movement) to 5 (immovable joint). | Baseline to: post-treatment (Day 0), Day 7, Day 30 | 
| Improvement in Spasm Frequency and Severity as Measured by the Penn Spasm Score | The Penn Spasm Score, which is a patient reported score, consists of two sub-scales: the spasm frequency score and the spasm severity scale3. The Penn spasm frequency is assessed on a 5-point scale from 0 (no spasms) to 4 (spasms occurring more than ten times per hour). The spasm severity scale consists of three ratings, which are 1 (mild), 2 (moderate) and 3 (severe). | Baseline to: post-treatment (Day 0), Day 7, Day 30 | 
| Improvement in Upper Extremity Motor Recovery as Measured by the Fugl-Meyer Scale (Post Stroke Subjects Only) | The Fugl-Meyer Scale is an assessment consisting of 33 movements, each rated as 0 (cannot perform), 1 (can partially perform) or 2 (can perform fully). A Subject's score is the sum of their ratings on each of these items, where the maximum (best) score is a 66. | Baseline to: post-treatment (Day 0), Day 7, Day 30 | 
| Subject Assessed Change in Mean Spasticity Numerical Rating Scale (NRS) Score | The NRS is an 11-point scale from 0 to 10, where lower scores represent less spasticity. | baseline to: post-treatment (Day 0), Day 7, Day 30 | 
| Improvement in Pain as Assessed by Visual Analog Scale (VAS) | Visual Analog Scale assesses pain on a 0-10 point range. 0= no pain and 10 is the worst pain imaginable. Higher score is associated with a worse outcome. | Baseline to: Post-treatment (Day 0), Day 7, Day 30 | 
| Duration of Treatment Effect | Subjects were asked to report the duration of treatment effect at Day 7,Day 30, and Day 56. Subjects could designate their results as effect no effect or no longer effective. Subjects reporting effect at Day 56 were followed to Day 84; those with effect at Day 84 continued to be followed to Day 112. | Day 7, Day 30, Day 56, Day 84, Day 112 |