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Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06036199
Study type Interventional
Source Children's National Research Institute
Contact Chima Oluigbo, MD
Phone 2024763531
Email coluigbo@childrensnational.org
Status Recruiting
Phase N/A
Start date January 26, 2024
Completion date August 2025

See also
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Completed NCT06307561 - The Effect of Dystonia Severity on Participation in Daily Living Activities and Caregivers in Children of Cerebral Palsy With Secondary Dystonia
Completed NCT03347240 - Neuroablation Versus Neuromodulation Techniques for Treatment of Secondary Dystonia N/A