Clinical trial NCT01863901: Study Evaluating Treatment of Upper Limb Spasticity Using the Cryo-Touch III Device
Official title: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment With the Cryo-Touch III Device for Upper Limb Spasticity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Limb Spasticity
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2013-05-29
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Male or female, 18 years of age and older.
2. Trial participants must have a confirmed diagnosis that results in spasticity involving muscle innervated by the musculocutaneous nerve (MCN).
3. Any medications must be maintained on a stable schedule for at least two weeks prior to treatment. No washout period is allowed.
4. Must have an average score on the Modified Ashworth Scale for Spasticity of ≥ 2 over the last 30 days in the elbow.
5. Subject, in the Investigator's opinion, will not be exposed to unacceptable risk by participation.

Exclusion Criteria:

1. Previous surgical intervention that altered the target neural anatomy of the upper limb.
2. Any injection (neurolytic, sclerosing, anesthetic, etc.) to the upper limb within the last 4 months.
3. Current enrollment in an investigational drug or device study that specifically targets spasticity management.
4. Allergy or intolerance to local anesthesia.
5. Any local skin condition at the treatment site that in the investigator's opinion would adversely affect treatment or outcomes.
6. Any chronic medication use (prescription, over-the-counter, etc.) that in the investigator's opinion would affect study participation or subject safety.
7. Diagnosis of cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, open and/or infected wounds.
8. Diagnosis of progressive neurologic diseases such as ALS.
9. 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.).

Primary outcomes:
measure: 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
timeFrame: Baseline to: post-treatment (Day 0), Day 7, Day 30
Secondary outcomes:
measure: Improvement in Spasticity as Measured by the Tardieu Scale
timeFrame: Baseline to: post-treatment (Day 0), Day 7, Day 30
measure: Improvement in Spasm Frequency and Severity as Measured by the Penn Spasm Score
timeFrame: Baseline to: post-treatment (Day 0), Day 7, Day 30
measure: Improvement in Upper Extremity Motor Recovery as Measured by the Fugl-Meyer Scale (Post Stroke Subjects Only)
timeFrame: Baseline to: post-treatment (Day 0), Day 7, Day 30
measure: Subject Assessed Change in Mean Spasticity Numerical Rating Scale (NRS) Score
timeFrame: baseline to: post-treatment (Day 0), Day 7, Day 30
measure: Improvement in Pain as Assessed by Visual Analog Scale (VAS)
timeFrame: Baseline to: Post-treatment (Day 0), Day 7, Day 30
measure: Duration of Treatment Effect
timeFrame: Day 7, Day 30, Day 56, Day 84, Day 112
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Kansas City Bone and Joint Clinic
state: Kansas
city: Paoli
country: United States
facility: Dr. Mitchell Paulin
state: Pennsylvania
Study officials:
References: