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Recruiting NCT07321366

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

No phase Interventional Cerebral Palsy (CP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cryoneurlysis.
Who it may be relevant to
Registry conditions: Cerebral Palsy (CP). Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy and Tolerability of Cryoneurolysis Treatment in Disabling and/or Painful Hypertonia of the Shoulder and Elbow in Patients With Cerebral Palsy Who Have Reached a Therapeutic Impasse a Pilot Study

Overview

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.

Interventions

  • 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 achievin

Primary outcome measures

  • Goal Assessment Scale [Time frame: 1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up]
Secondary outcome measures (6)
  • Clinical tolerability [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 [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 [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 [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 [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 [Time frame: 1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • CMCR des Massues — Lyon

Identifiers

NCT: NCT07321366 · 2025_06_OPCRYO_DM · 2025-A01180-49

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗