Actively Recruiting
Phase Not Applicable
Age: 8Years - 22Years
All Genders
NCT06036199
Focused Ultrasound Pallidotomy for Dyskinetic Cerebral Palsy in Pediatric and Young Adult Subjects
Led by Children's National Research Institute · Updated on 2025-02-11
10
Participants Needed
1
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Focused Ultrasound Pallidotomy for Dyskinetic Cerebral Palsy in Pediatric and Young Adult Subjects
Who Can Participate
Age: 8Years - 22Years
All Genders
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 1 location
1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
Loading map...
Research Team
C
Chima Oluigbo, MD
CONTACT
S
Saige Teti
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here