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New treatment option for Hemiplegia
Official title Upper Limb Nerve Cryoneurolysis is Non Inferior to the Usual Care and Has Therapeutic Add Value in Dealing With Shoulder Pain and Functional Problems Caused by Spasticity and Motor Impairment
ClinicalTrials.gov ID: NCT06782464
What this study is testing
- What it's testing
- This trial is part of the spastiCRYO clinical research project. The primary objective of this clinical trial is to test the hypothesis: "Upper limb nerve cryoneurolysis is non inferior to the usual care and has therapeutic add value in dealing with shoulder pain and functional problems caused by spasticity and motor impairment".
- Time commitment: about 4 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- Be over 18 years old.
- Have a clinically and functionally stable condition.
- Present spastic hemiplegia of the upper limb caused by a stroke, traumatic, or hypoxic brain event occurring more than 6 months before the study.
- The paretic upper limb must present significant spastic plegia at the shoulder adductors and/or shoulder internal rotators (≥ 1+ on the Modified...
- Have a Visual Analogue Scale (VAS) pain score \> 40/100 mm.
You likely can't join if
- In the investigator's opinion, the subject will be exposed to unacceptable risk by participation.
- Previous intervention or condition that altered the target neural anatomy of the upper limb.
- Any injection (neurolytic, sclerosing, anesthesia, etc.) to the upper limb within the last 4 months.
- Spasticity invasive treatment such as intrathecal baclofen during the trial.
- Current enrollment in an investigational drug or device study targeting spasticity management.
- Pregnancy or lactation.
See the full eligibility criteria
- Be over 18 years old.
- Have a clinically and functionally stable condition.
- Present spastic hemiplegia of the upper limb caused by a stroke, traumatic, or hypoxic brain event occurring more than 6 months before the study.
- The paretic upper limb must present significant spastic plegia at the shoulder adductors and/or shoulder internal rotators (≥ 1+ on the Modified Ashworth Scale).
- Have a Visual Analogue Scale (VAS) pain score \> 40/100 mm.
- Have spasticity causing limitations in providing care.
- Have the cognitive capacity to make informed decisions. A comprehensive explanation of the study will be provided orally and in writing to participants and a trusted relative of their choosing.
- Maintain any medications on a stable schedule.
- Accept and have access to an interdisciplinary rehabilitation program and standardized evaluation sessions throughout the study.
- In the investigator's opinion, the subject will be exposed to unacceptable risk by participation.
- Previous intervention or condition that altered the target neural anatomy of the upper limb.
- Any injection (neurolytic, sclerosing, anesthesia, etc.) to the upper limb within the last 4 months.
- Spasticity invasive treatment such as intrathecal baclofen during the trial.
- Current enrollment in an investigational drug or device study targeting spasticity management.
- Pregnancy or lactation.
- Allergy or intolerance to local anesthesia/BoNT-A.
- Contraindications to BoNT-A administration, such as:
- Myasthenia Gravis
- Eaton-Lambert syndrome
- Possible drug interactions (e.g., aminoglycosides and BoNT-A)
- Any local skin condition at the treatment site that may adversely affect treatment or outcomes.
- Chronic medication use (prescription or over-the-counter) that, in the investigator's opinion, would affect study participation or subject safety.
- Contraindications to cryoneurolysis, including:
- Diagnosis of cryoglobulinemia
- Paroxysmal cold hemoglobinuria
- Cold urticaria
- Raynaud's disease
- Any form of peripheral neuropathy
- Open and/or infected wounds on the affected limb
- Diagnosis of concomitant progressive neurological diseases such as Amyotrophic Lateral Sclerosis.
- Any reason, in the investigator's opinion, that the subject may not be suitable for study participation (e.g., history of noncompliance, drug addiction, or any related upper limb injury).
The study team makes the final eligibility decision.
Where it's taking place
- Luxembourg, Luxembourg
Compensation & support
Some study costs may be covered.
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 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 study runs about 4 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Luxembourg, Luxembourg. 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.