Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity

Conditions

• Spasticity, Cerebral or Spinal Condition

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• iovera° system — DEVICE
  subjects will receive ultrasound-guided iovera° system treatment
• sham iovera° system treatment — DEVICE
  subjects will receive ultrasound-guided iovera° sham system treatment

Study Details

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).

Key Dates

Start date

Jul 11, 2024

Status verified

Apr 2026

Primary completion

Aug 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

132 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: iovera° system treatment
• Sham Comparator: sham iovera° system treatment

Primary Outcome Measure

Change from baseline in the Modified Ashworth Scale score for elbow measured (0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity) [ Time Frame: at week 13 ]

Central Contacts

• Christine K. Brozyniak
  (973) 254-4364
  [email protected]

Locations (18)

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