Loading clinical trials...

Focused Ultrasound Pallidotomy for Dyskinetic Cerebral Palsy in Pediatric and Young Adult Subjects | Clinical Trials | Clareo Health

RECRUITINGNA

Focused Ultrasound Pallidotomy for Dyskinetic Cerebral Palsy in Pediatric and Young Adult Subjects

Safety and Impact on Quality of Life of Focused Ultrasound Pallidotomy for Dyskinetic Cerebral Palsy in Pediatric and Young Adult Subjects

NCT06036199•Children's National Research Institute

View on ClinicalTrials.gov

Summary

Detailed 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 patients will also be assessed.

Eligibility

Age

8 - 22 years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

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
+13 more criteria

Locations (1)

Children's National Hospital

Washington D.C., District of Columbia, United States

Key Dates

Start Date

January 26, 2024

Primary Completion Date

August 1, 2025

Completion Date

August 1, 2025

Last Updated

February 11, 2025

Enrollment

ESTIMATED participants

Conditions

Cerebral Palsy, DyskineticSecondary Dystonia

Interventions

Focused Ultrasound Pallidotomy

DEVICE

Contacts

Chima Oluigbo, MD

CONTACT

2024763531 coluigbo@childrensnational.org

Saige Teti

CONTACT

2024763755 sateti@childrensnational.org