NCT06036199 Focused Ultrasound Pallidotomy for Dyskinetic Cerebral Palsy in Pediatric and Young Adult Subjects
| NCT ID | NCT06036199 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's National Research Institute |
| Condition | Cerebral Palsy, Dyskinetic |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-01-26 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2024-01-26 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * 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 study-specific tests or procedures are performed Exclusion Criteria: * 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 forms of hormonal contraception ("antibaby-pill", hormonal plaster, NuvaRing®, Implanon®, hormonal depot injections, contraceptive coil), the tubal ligature (female sterilization). Alternatively, the female of child bearing potential is sexually abstinent. * Subjects who have contraindications to anesthesia, in the judgment of the attending anesthesiologist * Subjects 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.
Contact & Investigator
Chima Oluigbo, MD
PRINCIPAL INVESTIGATOR
Children's National Hospital, Washington, DC
Frequently Asked Questions
Who can join the NCT06036199 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 22 Years, studying Cerebral Palsy, Dyskinetic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06036199 currently recruiting?
Yes, NCT06036199 is actively recruiting participants. Contact the research team at coluigbo@childrensnational.org for enrollment information.
Where is the NCT06036199 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT06036199 clinical trial?
NCT06036199 is sponsored by Children's National Research Institute. The principal investigator is Chima Oluigbo, MD at Children's National Hospital, Washington, DC. The trial plans to enroll 10 participants.
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