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New treatment option for Cerebral Palsy, Dyskinetic
Official title Focused Ultrasound Pallidotomy for Dyskinetic Cerebral Palsy in Pediatric and Young Adult Subjects
ClinicalTrials.gov ID: NCT06036199
What this study is testing
- What it's testing
- The primary objective of the proposed study is to evaluate the safety of ExAblate Transcranial MRgFUS as a tool for creating bilateral or unilateral lesions in the globus pallidus (GPi) in patients with treatment-refractory secondary dystonia due to dyskinetic cerebral palsy
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 22
You may be able to join if
- The treating physician has chosen GPi-DBS or pallidotomy for the treatment of the secondary dystonia caused by cerebral palsy in this patient
- Patient and/or legal representative, if the patient is underaged or not capable to give consent himself, have chosen pallidotomy as treatment
- The consent to participate in the trial of the underaged patient, if he is capable to understand the study requirements, is required
- Age at enrolment 8-22 years
- Diagnosis of secondary dystonia due to cerebral palsy caused by perinatal hypoxic injury
You likely can't join if
- Patients with known primary (e.g. DYT1) or idiopathic dystonia
- Severe axial hypotonia with total loss of head control (e.g. absence of control at "upper thoracic level" in the SATCo score) (medication effect...
- Fixed hemi-dystonia
- Severe spasticity in knee- and elbow-flexors and -extensors (Modified Ashworth Scale \>3)
- Fixed severe skeletal contractions with loss of function which require immediate orthopaedic surgical intervention
- Patients with other severe concurrent neurological disease (e. g. brain tumor, neurodegenerative diseases, trauma etc.)
See the full eligibility criteria
Who can join
- The treating physician has chosen GPi-DBS or pallidotomy for the treatment of the secondary dystonia caused by cerebral palsy in this patient
- Patient and/or legal representative, if the patient is underaged or not capable to give consent himself, have chosen pallidotomy as treatment
- The consent to participate in the trial of the underaged patient, if he is capable to understand the study requirements, is required
- Age at enrolment 8-22 years
- Diagnosis of secondary dystonia due to cerebral palsy caused by perinatal hypoxic injury
- Anti-dystonic pharmacotherapy insufficient
- Stable anti-dystonic medication over the last 30 days
- Globus pallidus internus (pars posterior) and thalamus (motor part) intact on MRI (not older than 2 years - if possible)
- No fixed severe skeletal deformations with loss of function, which need immediate orthopaedic surgical intervention
- Sufficient compliance of the patient or the legal representative if the patient is underaged or not capable to give consent himself to take part in the study
- Informed consent to take part in the study from patient and/or legal representative if the patient is underaged or not capable to give consent himself
- Patient and/or legal representative if the patient is underaged or not capable to give consent himself, understands the study requirements and the treatment procedures and provides written informed consent before any...
What rules you out
- Patients with known primary (e.g. DYT1) or idiopathic dystonia
- Severe axial hypotonia with total loss of head control (e.g. absence of control at "upper thoracic level" in the SATCo score) (medication effect excluded)
- Fixed hemi-dystonia
- Severe spasticity in knee- and elbow-flexors and -extensors (Modified Ashworth Scale \>3)
- Fixed severe skeletal contractions with loss of function which require immediate orthopaedic surgical intervention
- Patients with other severe concurrent neurological disease (e. g. brain tumor, neurodegenerative diseases, trauma etc.)
- Condition likely to require use of MRI in the future
- Any intracranial abnormality or medical condition that would contraindicate DBS surgery
- Any findings in neuropsychological screening assessments that would contraindicate DBS surgery
- Any current drug and / or alcohol abuse
- Any history of frequent grand-mal seizures without response to anticonvulsive treatment
- Any other active implanted device (e.g. Cochlear implant, pacemaker), whether turned on or off, would be allowed provided that they do not interfere with functioning of the device.
- The presence of DBS leads due the risks of these ferromagnetic devices in the MRI environment.
- A history of neurostimulation intolerance in any area of the body.
- Currently on any anticoagulant medications that cannot be discontinued during perioperative period.
- Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival \<24 months.
- Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days; any other trial participation should be approved by the Principal Investigator.
- A female that is breastfeeding or of childbearing potential with a positive urine pregnancy test or - if a person is sexually active - not using sufficient contraception with a Pearl Index of less than 1% including all...
- people who have contraindications to anesthesia, in the judgment of the attending anesthesiologist
- people who are unwilling or unable to undergo general anesthesia
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.
- Minimum head circumference \< 49cm
- Skull Density Ratio (SDR) \<0.40.
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
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, 8 years to 22 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States. 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.