Muscle Elastography in Spastic Cerebral Palsy

Use of Elastography to Quantify Change in Upper Extremity Muscle Spasticity Following Botox Injection in Children With Spastic Cerebral Palsy

To date, clinical tests are unable to differentiate between the cause of muscle stiffness, although a manual instrumented spasticity assessment for the lower limb that utilizes surface electromyogram has recently been proposed. This study intends to use shear wave elastography to assess individual muscle stiffness parameters and the individual response to botulinum toxin injection in the elbow and wrist flexors. Collection of baseline spasticity parameters could then be used to predict the effect of botulinum toxin type A and ultimately serve as a basis for development of a treatment model for muscle spasticity in patients with spastic cerebral palsy.

Study Overview

• Status: Completed
• Conditions: Unilateral Spastic Cerebral Palsy
• Intervention / Treatment: Drug: Botulinum toxin type A

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with unilateral spastic CP with presence of dynamic muscle spasticity in the elbow and/or wrist flexors, who will be able to provide consent. Consent may be obtained from a parent or legal guardian, as applicable.

Description

Inclusion Criteria:

• Patients with unilateral spastic cerebral palsy with presence of dynamic muscle spasticity in the elbow and/or wrist flexors, who will be able to provide consent.
• Consent may be obtained from a parent or legal guardian, as applicable.

Exclusion Criteria:

• Prior surgical procedure in the affected upper extremity
• Unrelated orthopedic injury to the affected upper extremity
• Current oral or intrathecal antispasticity therapy
• Prior Botulinum toxin type A injection in preceding 6 months

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Elasticity	Change in muscle elasticity (in kilopascal )	From immediate pre-injection to 1 month post-injection.
Muscle Elasticity	Change in muscle elasticity (in m/s)	From immediate pre-injection to 1 month post-injection.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional measures	Functional measures (MAS)	immediately pre- and immediately post-injection, and at 1 month, 3 months and 6 months post-injection.
Functional measures	Functional measures (PROM)	immediately pre- and immediately post-injection, and at 1 month, 3 months and 6 months post-injection.

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Collaborators: Radiological Society of North America

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 14, 2017
• Primary Completion (ACTUAL): December 30, 2020
• Study Completion (ACTUAL): December 30, 2020

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (ACTUAL): April 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Muscle Spasticity; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 2016-628

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No