Trial record 16 of 171 for:    Hypertonia

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MyoScience, Inc
ClinicalTrials.gov Identifier:
NCT01863901
First received: May 22, 2013
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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 Intervention
Upper Limb Spasticity
Device: Treatment with Cryo-Touch III device

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by MyoScience, Inc:

Primary Outcome Measures:
  • Improvement of hypertonia of the upper arm [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Improvement of hypertonia of the upper arm as measured by the Modified Ashworth Scale at Day 7.


Secondary Outcome Measures:
  • Safety Endpoints [ Time Frame: 56 Days ] [ Designated as safety issue: Yes ]
    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:
  • Improvement in spasticity [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Improvement in spasticity as measured by the Tardieu Scale.


Estimated Enrollment: 19
Study Start Date: April 2013
Study Completion Date: October 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment with the Cryo-Touch III Device Device: Treatment with 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01863901

Locations
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
  More Information

No publications provided

Responsible Party: MyoScience, Inc
ClinicalTrials.gov Identifier: NCT01863901     History of Changes
Other Study ID Numbers: MYO-0709
Study First Received: May 22, 2013
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014