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

NCT ID: NCT07321366

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-22
• Study Completion Date: 2028-12-15

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cryoneurolise treatment

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

Group Type: EXPERIMENTAL

Cryoneurlysis

Intervention Type: 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.

Interventions

Cryoneurlysis

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• - Patients who have received a botulinum toxin injection (any location) within 3 months prior to inclusion.
• Change in analgesic and/or antispastic treatment within 5 weeks prior to inclusion - Refusal to allow the patient's medical data to be used for research purposes
• 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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CMCR des Massues

Lyon, Rhône, France

Site Status: RECRUITING

Countries

France

Facility Contacts

Dr Gaucher-Piola

Role: primary

julie.rozaire@croix-rouge.fr

+33 4 72 38 48 02

Other Identifiers

2025-A01180-49

Identifier Type: OTHER

Identifier Source: secondary_id

2025_06_OPCRYO_DM

Identifier Type: -

Identifier Source: org_study_id