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

NCT01863901 | Completed Results

• 1 other identifier: MYO-0709
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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.

Conditions

Upper Limb Spasticity

Outcome Measures

Primary Outcomes (1)

• Decrease in Pain and Symptoms Caused by Hypertonia in the Upper Arm as Measured by an Improvement of 1 Point or Greater on the Modified Ashworth Scale (MAS) at Day 7

  The Modified Ashworth Scale (MAS) is 6-point scale designed to assess muscle tone and spasticity through the flexion or extension of a joint. Muscle response is graded on a scale from 0 (no increase in muscle tone) to 4 (affected parts rigid in flexion or extension). This includes a 1+ rating, which further distinguishes the types of increase in muscle tone from those described by a 1 or 2 rating.

  Baseline to: post-treatment (Day 0), Day 7, Day 30

Secondary Outcomes (6)

• Improvement in Spasticity as Measured by the Tardieu Scale

  Baseline to: post-treatment (Day 0), Day 7, Day 30

• Improvement in Spasm Frequency and Severity as Measured by the Penn Spasm Score

  Baseline to: post-treatment (Day 0), Day 7, Day 30

• Improvement in Upper Extremity Motor Recovery as Measured by the Fugl-Meyer Scale (Post Stroke Subjects Only)

  Baseline to: post-treatment (Day 0), Day 7, Day 30

• Subject Assessed Change in Mean Spasticity Numerical Rating Scale (NRS) Score

  baseline to: post-treatment (Day 0), Day 7, Day 30

• Improvement in Pain as Assessed by Visual Analog Scale (VAS)

  Baseline to: Post-treatment (Day 0), Day 7, Day 30

Study Arms (1)

Treatment with the Cryo-Touch III Device

EXPERIMENTAL

Device: Treatment with Cryo-Touch III device

Interventions

Treatment with Cryo-Touch III device DEVICE

Treatment with the Cryo-Touch III Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.).

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (2)

Kansas City Bone and Joint Clinic

Overland Park, Kansas, 66211, United States

Location

Dr. Mitchell Paulin

Paoli, Pennsylvania, 19301, United States

Location

MeSH Terms

Interventions

Therapeutics

Results Point of Contact

• Title: Medical Information
• Organization: Pacira Bioscience, Inc.

MedInfo@Pacira.com

1-855-793-9729

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: May 29, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: October 1, 2013
• Last Updated: January 24, 2024
• Results First Posted: June 27, 2023

Record last verified: 2024-01

Locations

US (2)