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Tests treatment safety and results for Cerebral Palsy (CP)
Official title 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
ClinicalTrials.gov ID: NCT07321366
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Patients with cerebral palsy treated at the CMCR des Massues, regardless of their functional status as defined by their gross motor function level on...
- 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 how well it works of oral treatments (analgesics...
- Patient (and legal representatives in the case of a minor patient or guardian/curator in the case of an adult patient under legal protection...
You likely can't join if
- \- 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...
- Contraindication to peripheral motor block and/or cryoneurolysis (haemostasis disorder, skin infection, Raynaud's syndrome, cryoglobulinaemia, cold...
- Pregnant/breastfeeding patients.
- Cognitive and/or behavioural disorders that prevent participation in the study or giving consent to participate
See the full eligibility 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...
- 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 how well it works of oral treatments (analgesics, baclofen, Artane), too short duration of how well it works of toxin...
- 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...
- Patient affiliated with a social security scheme.
- \- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lyon, Rhône, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lyon, Rhône, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.