A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment With the Cryo-Touch III Device for Upper Limb Spasticity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- 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
研究概览
简要总结
A proof of concept study to evaluate the feasibility of safe and effective treatment of upper limb spasticity using the Cryo-Touch III Device.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.).
结局指标
主要结局
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
时间窗: Baseline to: post-treatment (Day 0), Day 7, Day 30
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.
次要结局
- Improvement in Upper Extremity Motor Recovery as Measured by the Fugl-Meyer Scale (Post Stroke Subjects Only)(Baseline to: post-treatment (Day 0), Day 7, Day 30)
- Improvement in Spasm Frequency and Severity as Measured by the Penn Spasm Score(Baseline to: post-treatment (Day 0), Day 7, Day 30)
- Subject Assessed Change in Mean Spasticity Numerical Rating Scale (NRS) Score(baseline to: post-treatment (Day 0), Day 7, Day 30)
- Improvement in Pain as Assessed by Visual Analog Scale (VAS)(Baseline to: Post-treatment (Day 0), Day 7, Day 30)
- Duration of Treatment Effect(Day 7, Day 30, Day 56, Day 84, Day 112)
- Improvement in Spasticity as Measured by the Tardieu Scale(Baseline to: post-treatment (Day 0), Day 7, Day 30)