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Compares treatment options for Stroke
Official title Evaluation of Percutaneous Cryoneurotomy Compared to Surgical Open Neurotomy for the Management of Equinovarus Foot Deformity in Patients With Refractory Lower Limb Spasticity After Stroke
ClinicalTrials.gov ID: NCT06726434
What this study is testing
- What it's testing
- CRYOSTROKE study is designed : to compare the efficacy and safety of percutaneous CryoNeurotomie (CN) versus surgical neurotomy (SN) on spasticity, 90 days after intervention, in post-stroke patients presenting with spastic equinovarus foot and, to ensure that potential clinical effect/safety remain stable within time, with a 12-month follow-up.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years old.
- Patient with spastic equinovarus foot as a result of stroke in chronic phase (\>6 months).
- Patient with positive perineural motor block test with or without complete correction of spastic equinus and non-persistence of 40° equinus.
- Patient eligible for surgical neurotomy for varus equinus foot.
- Patient presenting no cognitive impairment or major depression (Mini Mental State Examination\>20, Hospital Anxiety and Depression (HAD\<11)).
You likely can't join if
- Patient with previous nerve procedures such as chemical neurolysis with alcohol, cryoneurotomy, or any surgery at the same anatomical site.
- Patient with any neurological pathology different from the one responsible for the spasticity.
- Patient with botulinum toxin in lower limb injection during the last 90 days before intervention.
- Patient with anti-spastic treatment (baclofene) up 3 days before block test.
- Patient with total deficit of valgus muscles.
- Patient with equinus foot \> 40° (retractions/ankylosis).
See the full eligibility criteria
- Age ≥18 years old.
- Patient with spastic equinovarus foot as a result of stroke in chronic phase (\>6 months).
- Patient with positive perineural motor block test with or without complete correction of spastic equinus and non-persistence of 40° equinus.
- Patient eligible for surgical neurotomy for varus equinus foot.
- Patient presenting no cognitive impairment or major depression (Mini Mental State Examination\>20, Hospital Anxiety and Depression (HAD\<11)).
- Absence of active psychosis or history of serious psychotic illness requiring hospitalization
- Patient understanding and accepting the constraints of the study.
- Patient covered by French national health insurance.
- Patient who has given their written consent to the study after having received clear information.
- Patient with previous nerve procedures such as chemical neurolysis with alcohol, cryoneurotomy, or any surgery at the same anatomical site.
- Patient with any neurological pathology different from the one responsible for the spasticity.
- Patient with botulinum toxin in lower limb injection during the last 90 days before intervention.
- Patient with anti-spastic treatment (baclofene) up 3 days before block test.
- Patient with total deficit of valgus muscles.
- Patient with equinus foot \> 40° (retractions/ankylosis).
- Surgical and anesthetic contra-indications (severe uncontrolled coagulation disorder, active infection).
- Cryoneurotomy contra-indications (cold intolerance, cryoglobulinemia, cryofibrinogenemia, Raynaud's phenomena, venous thromboemolism (\< 3 months if superficial, \< 6 months if deep), hypothyreosis, cold urticari, local...
- Subject requiring closer protection, i.e. minors, pregnant women, nursing mothers, people deprived of their freedom by a court or administrative decision, people admitted to a health or social welfare establishment...
- Pregnant woman, nursing mother, woman of childbearing potential not using effective contraception (hormonal/barrier: oral, parenteral, percutaneous, implantable, intrauterine device, or surgical: tubal ligation...
The study team makes the final eligibility decision.
Where it's taking place
- Garches, France
- Montpellier, France
- Poitiers, France
- Rennes, France
- Saint-Etienne, France
- Toulouse, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Garches, France; Montpellier, France; Poitiers, France; Rennes, France; Saint-Etienne, France; Toulouse, France. Enter your location above to see the nearest site and check your eligibility.
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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.