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

Launched by PACIRA PHARMACEUTICALS, INC · May 23, 2013

Keywords

ClinConnect Summary

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 ce...

Gender

ALL

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.).