An interventional study of Cryoneurlysis in Cerebral Palsy (CP), sponsored by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française. Recruiting at 1 site in France. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française · Not applicable, Interventional, and Treatment
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.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's planned enrollment of 40 is above the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française is the lead sponsor of 12 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After testing the function following treatment with a motor block, the patient receives an indication for cryoneurolysis treatment.
Procedure: 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.
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.
Time frame: 1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up
Clinical tolerability
The evaluation will be carried out, on the one hand, by quantifying the occurrence of adverse events following cryoneurolysis treatment. Once the effects have been confirmed, classification will be carried out by referring to the different grades of clinical classification on the NCI CTCAE version 5.0 scale (Common Terminology Criteria for Adverse Events).
Time frame: After cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up
Change in muscle structure
The change in muscle structure of the muscles innervated by the cryoneurolysed nerve will be assessed using the modified Heckmatt scale. This scale allows for the evaluation of potential echogenic changes in spastic muscles (echogenicity), indicating the level of fibrotic change.
Time frame: 1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up
Muscle hyperactivity
The modified Ashworth scale (19,20) will be used to quantify spasticity in patients who exhibit resistance to passive mobilisation (muscle hyperactivity). The average absolute variation in muscle response to stretching applied at given speeds will be assessed using the Modified Tardieu Scale (MTS).
Time frame: 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
Active range of motion (AROM) - movement of a joint performed entirely by the person doing the exercise - and passive range of motion (PROM) - movement applied to a joint solely by another person - in the shoulder and elbow will be measured using a goniometer.
Time frame: 1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up
Joint Pain
To assess pain in relation to a specific location in the shoulder and/or elbow, several tools can be used. We will preferably use a visual analogue scale from 0 to 10 to assess We prefer to use the Visual Analogue Scale from 0 to 10 to assess the intensity of pain. According to this self-assessment scale, the patient requires pain management if VAS ≥ 4/10.
Time frame: 1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up
Average Patient Satisfaction
The average patient satisfaction in relation to the overall sensation in the event of a change will be assessed using a visual analogue scale (VAS), presented vertically to the patient and/or their carer. This scale has two sides (depending on the patient's age and cognitive level), with one side illustrated by emoticons of different colours corresponding to a score of 0: not at all satisfied to 10: perfectly satisfied, and one side in the form of a graduated scale from 0 to 10.
Time frame: 1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up
Started Dec 2025 (actual). Primary completion is estimated for Dec 2028, 35 months after the start.
Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 35 months is above that.
Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française