Pilot Study on the Efficacy and Tolerability of Cryoneurolysis Treatment in Disabling and/or Painful Hypertonia of the Shoulder and Elbow in Patients With Cerebral Palsy

NCT07321366 | Recruiting

• 2 other identifiers: 2025_06_OPCRYO_DM2025-A01180-49
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to evaluate the achievement of personalised short- and medium-term objectives of this selective treatment of hypertonia by ultrasound-guided perineural percutaneous cryoneurolysis at the shoulder and elbow, in a population of patients with cerebral palsy with spastic, dyskinetic or dyskinetic, or mixed disorders.

Conditions

Cerebral Palsy (CP)

Outcome Measures

Primary Outcomes (1)

• Goal Assessment Scale

  Goal Assessment Scale is an individualized patient-centered outcome measure that quantifies the effects of an intervention based on personal goals. It involves collaboration among patients, caregivers, and healthcare professionals to identify and set meaningful treatment goals. GAS allows for the measurement of the extent to which these goals are met, providing a standardized approach to evaluate progress.

  1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up

Secondary Outcomes (6)

• Clinical tolerability

  After cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up

• Change in muscle structure

  1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up

• Muscle hyperactivity

  1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up

• Active range of motion

  1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up

• Joint Pain

  1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up

Study Arms (1)

Cryoneurolise treatment

EXPERIMENTAL

After testing the function following treatment with a motor block, the patient receives an indication for cryoneurolysis treatment.

Procedure: Cryoneurlysis

Interventions

Cryoneurlysis PROCEDURE

Ultrasound-guided percutaneous cryoneurolysis (CN) is a new, minimally invasive approach that allows the treatment of hypertonia by reversibly blocking nerve conduction secondary to axonotmesis. Although this approach has shown promising results with real benefits in the management of spasticity, its efficacy has not been determined in CP. CN therefore represents a therapeutic alternative between toxin injections and radical surgery in the management of complex tone disorders in CP, for achieving individualised objectives, including pain relief.

Cryoneurolise treatment

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with cerebral palsy treated at the CMCR des Massues, regardless of their functional status as defined by their gross motor function level on the GMFCS (Gross Motor Function Classification System) and their manual ability level on the MACS (Manual Ability Classification System).
• Presenting with disabling and/or painful muscle hyperactivity in the shoulder and/or elbow,
• Aged over 12 years,
• At a therapeutic impasse: contraindicated or refusing surgery, contraindication or insufficient efficacy of oral treatments (analgesics, baclofen, Artane), too short duration of efficacy of toxin injections (\<3 months) and/or dose-weight limitation not allowing treatment of all necessary sites.
• Patient (and legal representatives in the case of a minor patient or guardian/curator in the case of an adult patient under legal protection measures) who has been informed and has signed the informed consent form for participation in the research,
• Patient affiliated with a social security scheme.

You may not qualify if:

• Contraindication to peripheral motor block and/or cryoneurolysis (haemostasis disorder, skin infection, Raynaud's syndrome, cryoglobulinaemia, cold urticaria).
• Pregnant/breastfeeding patients.
• Cognitive and/or behavioural disorders that prevent participation in the study or giving consent to participate

Sponsors & Collaborators

• Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française: lead

Study Sites (1)

CMCR des Massues

Lyon, Rhône, 69003, France

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 7, 2026
• Study Start: December 22, 2025
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): December 15, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

FR (1)