Safety and Impact on Quality of Life of Focused Ultrasound Pallidotomy for Dyskinetic Cerebral Palsy in Pediatric and Young Adult Subjects
Children's National Research Institute
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
Description
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. The secondary is to assess the impact on Quality of Life of Focused Ultrasound Bilateral and unilateral Pallidotomy for Dyskinetic Cerebral Palsy in Pediatric and Young Adult Subjects. In addition, the impact of bilateral pallidotomy on motor development, pain perception, speech, memory, attention and cognition in these…
Eligibility
- Age range
- 8–22 years
- Sex
- All
- Healthy volunteers
- No
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 ins…
Interventions
- DeviceFocused Ultrasound Pallidotomy
Use of ExAblate Transcranial MR guided Focused Ultrasound 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
Location
- Children's National HospitalWashington D.C., District of Columbia