Cryoneurolysis for disabling or painful shoulder and elbow hypertonia in cerebral palsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center pilot offers ultrasound-guided percutaneous perineural cryoneurolysis targeted to nerves supplying spastic or dyskinetic muscles around the shoulder and elbow in people with cerebral palsy. Participants are patients treated at the CMCR des Massues who have disabling or painful hypertonia and who have reached a therapeutic impasse with oral drugs, botulinum toxin, or surgery. The protocol sets personalized short- and medium-term functional goals and collects clinical and patient-reported outcomes to characterize tolerability and preliminary efficacy. The focus is feasibility, safety, and estimating effect sizes to inform larger studies.

Why it matters

Who can join: the full rules

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

Where it's running

• CMCR des Massues
  Lyon, Rhône, France Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.