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

Completed · Not applicable

Conditions studied: Upper Limb Spasticity

In brief

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

Key facts

Study ID

NCT01863901

Run by

Pacira Pharmaceuticals, Inc

People needed

19

Starts

2013-04-01

Expected to finish

2013-10-01

Last updated by the study team

2024-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.).

Where it is running

• Kansas City Bone and Joint Clinic — Overland Park, Kansas, United States
• Dr. Mitchell Paulin — Paoli, Pennsylvania, United States

Full record on ClinicalTrials.gov

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