Cerebral Palsy (CP)OP-CRYONCT07321366
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
A study testing Cryoneurlysis in people with Cerebral Palsy (CP), run by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Cryoneurlysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 22 Dec 2025to 15 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CMCR des Massues
Lyon, Rhône, 69003
Dr Gaucher-Piola, +33 4 72 38 48 02, julie.rozaire@croix-rouge.fr
About this study
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
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)
- Being tested
- Cryoneurlysis
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoneurlysisProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Cryoneurolise treatment | Experimental | After testing the function following treatment with a motor block, the patient receives an indication for cryoneurolysis treatment. Receives: Procedure: Cryoneurlysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start22 Dec 2025
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321366
- Sponsor's protocol ID
- 2025_06_OPCRYO_DM
- Other IDs
- 2025-A01180-49
- Acronym
- OP-CRYO
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07321366
- Acronym / sponsor ID
- OP-CRYO / 2025_06_OPCRYO_DM
- Conditions
- Cerebral Palsy (CP)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge FrançaiseUniversity, hospital or other
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 15 Dec 2028 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryoneurolise treatment | Experimental | Procedure: CryoneurlysisAfter testing the function following treatment with a motor block, the patient receives an indication for cryoneurolysis treatment. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoneurlysisUltrasound-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. | Procedure or surgery | Cryoneurolise treatment |
Primary outcome
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
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoneurlysis in people with Cerebral Palsy (CP), run by Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.