iovera° System for Muscle Spasms

Recruiting at15 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Pacira Pharmaceuticals, Inc

Must be taking: Oral baclofen

Must not be taking: Neurotoxins, Phenol, Ethyl alcohol

Disqualifiers: Stroke, Brain injury, Spinal injury, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This multicenter, randomized, double-blind, sham-controlled study is designed to evaluate the efficacy and safety of the iovera° system in subjects with upper extremity spasticity. A total of approximately 132 subjects will be enrolled; 88 subjects will receive treatment with the iovera° system and 44 subjects will receive sham treatment (sham iovera° system treatment).

Do I have to stop taking my current medications for the trial?

If you are taking oral medications for spasticity, you must keep the dose stable for at least 4 weeks before the study. If you use an intrathecal baclofen pump, the dose must be stable for six months before the study.

How does the Iovera° System treatment for muscle spasms differ from other treatments?

The Iovera° System is unique because it uses a focused cold therapy to target and temporarily deactivate nerves, which can help reduce muscle spasms without the need for drugs or surgery. This approach is different from traditional treatments that often rely on medications or invasive procedures. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

This trial is for adults with cerebral palsy or muscle spasms causing stiffness in the shoulder and elbow. Participants must have been diagnosed at least 6 months prior, not be on varying oral spasticity meds, or if using a baclofen pump, it should be stable for six months. They need to show improvement after a lidocaine nerve block test.

Inclusion Criteria

I am 18 years old or older.

Subject, in the investigator's opinion, will not be exposed to unacceptable risk by participation

Able to provide informed consent, adhere to the study schedule, and complete all study assessments

Exclusion Criteria

Allergy or intolerance to amide local anesthetics

I have been diagnosed with a condition affected by cold, such as cryoglobulinemia, cold urticaria, or Raynaud's.

Subject is unable to adhere to the assessment schedule

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

1 visit (in-person)

Treatment

Participants receive either the iovera° system treatment or sham treatment on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for efficacy and safety outcomes post-treatment

13 weeks

3 visits (in-person) at Week 3, Week 7, and Week 13

Treatment Details

Interventions

• Iovera®° System (Procedure)

Trial Overview The study tests the iovera° system's effectiveness and safety against sham treatment in reducing upper extremity spasticity. Of the participants, two-thirds will receive actual iovera° treatment while one-third will get a sham procedure, decided randomly.

Participant Groups

Group I: iovera° system treatment Active Control 1 Intervention

Group II: sham iovera° system treatment Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Pacira Pharmaceuticals, Inc

Lead Sponsor

Trials

142

Recruited

14,300+

Headquarters

Tampa, USA

Known For

Non-opioid Pain Management

Top Products

Exparel, Zilretta, iovera

Dr. Jonathan Slonin

Pacira Pharmaceuticals, Inc

Chief Medical Officer since 2020

BSc in Biomedical Engineering and MD from University of Miami, MBA from George Washington University

Frank D. Lee

Pacira Pharmaceuticals, Inc

Chief Executive Officer since 2024

BSc in Chemical Engineering from Vanderbilt University, MBA from Wharton Graduate School of Business

Findings from Research

Muscular vibrations in relaxed and contracted skeletal muscles were successfully recorded using a piezo-electric device, revealing distinct frequency patterns that depend on muscle type and function.

The study suggests that these vibrations are primarily caused by the activity of motor units and central reflex loops, indicating that Computer-Vibromyography can enhance our understanding of muscle function alongside traditional EMG techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The computer-vibromyography as a biometric progress in studying muscle function. Keidel, M., Keidel, WD.[2019]

A new technique using accelerometers can objectively monitor and quantify muscle spasms in individuals with spinal cord injuries, distinguishing them from other movements like wheelchair use or transfers.

The method correlates well with muscle activity and allows for precise measurement of spasm duration, magnitude, and energy, making it a promising clinical tool for evaluating and treating spasms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of air bag technology: an objective clinical measure of involuntary muscle spasm. Granat, MH., Edmond, P.[2019]

Mechanical stimulation of the quadriceps muscle through sinusoidal vibrations led to significant improvements in motor performance, including a 27.8% decrease in time to develop force and a 40.3% increase in fatigue resistance in subjects performing voluntary contractions.

These results suggest that mechanical stimulation can induce lasting changes in motor control and proprioception, making it a promising tool for enhancing sports training and rehabilitation practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor performance changes induced by muscle vibration. Fattorini, L., Ferraresi, A., Rodio, A., et al.[2018]

In a study analyzing electromyographic (EMG) records from four subjects with chronic cervical spinal cord injury, two raters showed high agreement (89%) in classifying different types of muscle spasms, indicating that EMG is a reliable method for objective spasm assessment.

Most variability in spasm counts was due to differences between muscles rather than between subjects or raters, suggesting that muscle-specific factors play a significant role in spasm occurrence and that automated software could improve consistency in spasm identification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification and classification of involuntary leg muscle contractions in electromyographic records from individuals with spinal cord injury. Thomas, CK., Dididze, M., Martinez, A., et al.[2021]

The development of integrated musculoskeletal modeling tools allows for the safe and efficient design and evaluation of controllers for functional electrical stimulation (FES) before clinical trials, enhancing research in neuromusculoskeletal systems.

The Musculoskeletal Modeling in Simulink (MMS) and virtual muscle software enable the creation of anatomically accurate models without coding, facilitating complex simulations and improving the understanding of muscle responses to FES.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced modeling environment for developing and testing FES control systems. Davoodi, R., Brown, IE., Loeb, GE.[2019]

References

1. Germany pubmed.ncbi.nlm.nih.gov

The computer-vibromyography as a biometric progress in studying muscle function. [2019]

2. England pubmed.ncbi.nlm.nih.gov

The application of air bag technology: an objective clinical measure of involuntary muscle spasm. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Motor performance changes induced by muscle vibration. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Identification and classification of involuntary leg muscle contractions in electromyographic records from individuals with spinal cord injury. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Advanced modeling environment for developing and testing FES control systems. [2019]