Focused Ultrasound Pallidotomy for Dyskinetic Cerebral Palsy in Pediatric and Young Adult Subjects
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-22
SponsorChildren's National Research Institute
About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Focused Ultrasound Pallidotomy
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov