Upper Limb SpasticityNCT01863901
Study Evaluating Treatment of Upper Limb Spasticity Using the Cryo-Touch III Device
A study testing Treatment with Cryo-Touch III device in people with Upper Limb Spasticity, run by Pacira Pharmaceuticals, Inc at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Limb Spasticity
- What is being tested?
- Treatment with Cryo-Touch III device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2013to Oct 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kansas City Bone and Joint Clinic
Overland Park, Kansas, 66211
Dr. Mitchell Paulin
Paoli, Pennsylvania, 19301
About this study
Official title: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment With the Cryo-Touch III Device for Upper Limb Spasticity
A proof of concept study to evaluate the feasibility of safe and effective treatment of upper limb spasticity using the Cryo-Touch III Device.
Read the 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.
- Conditions
- Upper Limb Spasticity
- Being tested
- Treatment with Cryo-Touch III device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with Cryo-Touch III deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Treatment with the Cryo-Touch III Device | Experimental | Not described Receives: Device: Treatment with Cryo-Touch III device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to: post-treatment (Day 0), Day 7, Day 30
Secondary outcomes (6)
Improvement in Spasticity as Measured by the Tardieu Scale
The Tardieu Scale uses the application of stretch at several velocities to quantify muscle response and assess muscle spasticity. Two specified velocities were assessed (V1 and V2). For each stretch, quality of muscle reaction (X) is recorded on a 6-point scale from 0 (no resistance throughout passive movement) to 5 (immovable joint).
Measured: Baseline to: post-treatment (Day 0), Day 7, Day 30
Improvement in Spasm Frequency and Severity as Measured by the Penn Spasm Score
The Penn Spasm Score, which is a patient reported score, consists of two sub-scales: the spasm frequency score and the spasm severity scale3. The Penn spasm frequency is assessed on a 5-point scale from 0 (no spasms) to 4 (spasms occurring more than ten times per hour). The spasm severity scale consists of three ratings, which are 1 (mild), 2 (moderate) and 3 (severe).
Measured: 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)
The Fugl-Meyer Scale is an assessment consisting of 33 movements, each rated as "0" (cannot perform), "1" (can partially perform) or "2" (can perform fully). A Subject's score is the sum of their ratings on each of these items, where the maximum (best) score is a 66.
Measured: Baseline to: post-treatment (Day 0), Day 7, Day 30
Subject Assessed Change in Mean Spasticity Numerical Rating Scale (NRS) Score
The NRS is an 11-point scale from 0 to 10, where lower scores represent less spasticity.
Measured: baseline to: post-treatment (Day 0), Day 7, Day 30
Improvement in Pain as Assessed by Visual Analog Scale (VAS)
Visual Analog Scale assesses pain on a 0-10 point range. 0= no pain and 10 is the worst pain imaginable. Higher score is associated with a worse outcome.
Measured: Baseline to: Post-treatment (Day 0), Day 7, Day 30
Duration of Treatment Effect
Subjects were asked to report the duration of treatment effect at Day 7,Day 30, and Day 56. Subjects could designate their results as "effect" "no effect" or "no longer effective". Subjects reporting "effect" at Day 56 were followed to Day 84; those with effect at Day 84 continued to be followed to Day 112.
Measured: Day 7, Day 30, Day 56, Day 84, Day 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Upper Limb SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863901
- Sponsor's protocol ID
- MYO-0709
- Status last verified
- Jan 2024
- First submitted
- 22 May 2013
- Last updated
- 24 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment With the Cryo-Touch III Device for Upper Limb Spasticity
- ClinicalTrials.gov ID
- NCT01863901
- Acronym / sponsor ID
- MYO-0709
- Conditions
- Upper Limb Spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 29 May 2013 (estimated)
- Results
- Posted 27 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with the Cryo-Touch III Device | Experimental | Device: Treatment with Cryo-Touch III device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with Cryo-Touch III device | Device | Treatment with the Cryo-Touch III Device |
Primary outcome
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
Time frame: Baseline to: post-treatment (Day 0), Day 7, Day 30
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.
6 secondary outcomes
Improvement in Spasticity as Measured by the Tardieu Scale
Time frame: Baseline to: post-treatment (Day 0), Day 7, Day 30
Improvement in Spasm Frequency and Severity as Measured by the Penn Spasm Score
Time frame: 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)
Time frame: Baseline to: post-treatment (Day 0), Day 7, Day 30
Subject Assessed Change in Mean Spasticity Numerical Rating Scale (NRS) Score
Time frame: baseline to: post-treatment (Day 0), Day 7, Day 30
Improvement in Pain as Assessed by Visual Analog Scale (VAS)
Time frame: Baseline to: Post-treatment (Day 0), Day 7, Day 30
Duration of Treatment Effect
Time frame: Day 7, Day 30, Day 56, Day 84, Day 112
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Upper Limb Spasticity
RecruitingPhase 1
Shockwave for Elbow and Wrist Spasticity in People With Spinal Cord Injury
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Active, not recruitingPhase 3
Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury
Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury
Active, not recruiting
FlexWave Trial: Efficacy of Extracorporeal Shock Wave Therapy in Post-Stroke Upper Limb Spasticity
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Not yet recruiting
Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy.
Cerebral Palsy Spastic Hemiplegic, Functionnal Neurological Disorder
RecruitingPhase 2
A Pilot Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368, a FAAH/MAGL Inhibitor, in Participants With Post-Stroke Spasticity (The STIPS Study)
Post-Stroke Spasticity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with Cryo-Touch III device in people with Upper Limb Spasticity, run by Pacira Pharmaceuticals, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline to: post-treatment (Day 0), Day 7, Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.