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Assessing the iovera° system for treating upper extremity spasticity

A Multicenter, Randomized, Double-Blind, Sham-Controlled Study Assessing the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity

Not applicable Interventional Pacira Pharmaceuticals, Inc · NCT06340451

This study is testing if the iovera° system can help people with upper extremity spasticity from brain or spinal conditions feel better by using targeted nerve injections.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment132 (estimated)
Ages18 Years and up
SexAll
SponsorPacira Pharmaceuticals, Inc Industry-sponsored
Locations18 sites (Downey, California and 17 other locations)
Trial IDNCT06340451 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, sham-controlled study evaluates the efficacy and safety of the iovera° system in patients with upper extremity spasticity due to cerebral or spinal conditions. Approximately 132 subjects will be enrolled, with 88 receiving the iovera° treatment and 44 receiving a sham treatment. Participants will undergo assessments using the Modified Ashworth Scale, Modified Tardieu Scale, and Goal Attainment Scale before and after treatment. The treatment involves ultrasound-guided injections targeting specific nerves associated with muscle control in the shoulder and elbow.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of a cerebral or spinal condition causing upper extremity spasticity for at least six months.

Not a fit: Patients currently using oral medications for spasticity management or those with an intrathecal baclofen pump may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce spasticity and improve upper extremity function in affected patients.

How similar studies have performed: Other studies have shown promise in using similar nerve-targeting approaches for spasticity management, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male or female, 18 years and above.
2. A confirmed diagnosis of any cerebral or spinal condition, at least 6 months before Screening, resulting in spasticity of the muscles controlling the shoulder and elbow.
3. Not on oral medications for spasticity management or if on any oral medications, the oral medication taken chronically for spasticity management (eg, oral baclofen) must be maintained at a stable dose for at least 4 weeks before screening for the study.
4. Not on an intrathecal baclofen pump or if on an intrathecal baclofen pump for spasticity management, must be maintained at a stable dose for six months or more before screening for the study.
5. Must have a score on the Modified Ashworth Scale of 2 or more in the targeted area (shoulder and elbow) at Screening and at Baseline (Day-1 pretreatment).
6. A diagnostic nerve block using lidocaine (1% lidocaine, 2 to 3 mL per target nerve) showing a positive response (at least one point reduction from the screening Modified Ashworth Scale score for elbow extension and shoulder abduction) to the targeted nerves, should be performed within 30 days to at least 6 hours before study treatment. The diagnostic nerve block effect must be completely resolved before pretreatment evaluation and the study treatment.
7. Subject, in the investigator's opinion, will not be exposed to unacceptable risk by participation.
8. Able to provide informed consent, adhere to the study schedule, and complete all study assessments.

Exclusion Criteria:

1. History of stroke, traumatic brain injury, and/or spinal cord injury in less than 6 months.
2. Diagnosis of cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, or Raynaud's disease.
3. History of neurotoxin injections within the past 3 months.
4. Previous injection with phenol or ethyl alcohol at any time in the target areas (shoulder or elbow).
5. Previous surgical intervention that altered the target neuroanatomy of the upper limb.
6. Current or planned enrollment in an investigational drug or device study for the management of spasticity for the duration of the study.
7. Medical instability that interferes with tolerability to spasticity treatment with the study device as per the investigator's discretion.
8. Any hospitalization within 4 weeks before Screening
9. Diagnosis of amyotrophic lateral sclerosis or any lower motor neuron conditions
10. Allergy or intolerance to amide local anesthetics.
11. Any skin condition in or around the target area that, in the opinion of the investigator, could adversely impact treatment.
12. Currently pregnant, nursing, or planning to become pregnant during the study.
13. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
14. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance.
15. Subject, in the opinion of the investigator, is not a suitable candidate for study participation (eg, history of multiple missed office visits, any related upper limb injury).
16. Subject is unable to adhere to the assessment schedule.

Where this trial is running

Downey, California and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Spasticity, Cerebral or Spinal ConditionspasticitycerebralSpinal
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.