Status:
COMPLETED
Study Evaluating Treatment of Upper Limb Spasticity Using the Cryo-Touch III Device
Lead Sponsor:
Pacira Pharmaceuticals, Inc
Conditions:
Upper Limb Spasticity
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.).
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01863901
Start Date
April 1 2013
End Date
October 1 2013
Last Update
January 24 2024
Active Locations (2)
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1
Kansas City Bone and Joint Clinic
Overland Park, Kansas, United States, 66211
2
Dr. Mitchell Paulin
Paoli, Pennsylvania, United States, 19301