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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01863901
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : April 18, 2016
Information provided by (Responsible Party):
MyoScience, Inc

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.

Condition or disease Intervention/treatment Phase
Upper Limb Spasticity Device: Treatment with Cryo-Touch III device Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment With the Cryo-Touch III Device for Upper Limb Spasticity
Study Start Date : April 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
Experimental: Treatment with the Cryo-Touch III Device Device: Treatment with Cryo-Touch III device

Primary Outcome Measures :
  1. Improvement of hypertonia of the upper arm [ Time Frame: 7 days ]
    Improvement of hypertonia of the upper arm as measured by the Modified Ashworth Scale at Day 7.

Secondary Outcome Measures :
  1. Safety Endpoints [ Time Frame: 56 Days ]
    Adverse events, serious adverse events (SAE) and unanticipated adverse device effects (UADE) will be assessed at all visits. Incidence of SAEs and UADEs will be recorded. A serious adverse event is one that meets the ISO definition of SAE.

Other Outcome Measures:
  1. Improvement in spasticity [ Time Frame: 7 days ]
    Improvement in spasticity as measured by the Tardieu Scale.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01863901

United States, Kansas
Kansas City Bone and Joint Clinic
Overland Park, Kansas, United States, 66211
United States, Pennsylvania
Dr. Mitchell Paulin
Paoli, Pennsylvania, United States, 19301
Sponsors and Collaborators
MyoScience, Inc

Responsible Party: MyoScience, Inc Identifier: NCT01863901     History of Changes
Other Study ID Numbers: MYO-0709
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms