Focused Ultrasound Pallidotomy for Dyskinetic Cerebral Palsy

This study is looking at the safety of a procedure called Focused Ultrasound Pallidotomy using a device called ExAblate Transcranial MR guided Focused Ultrasound. This procedure creates small, targeted changes in a specific part of the brain (the globus pallidus, or GPi) to help with severe, uncontrolled movements (dystonia) caused by dyskinetic cerebral palsy. The study is for children and young adults aged 8 to 22 years old who have severe dystonia from cerebral palsy that hasn't responded to other treatments. Doctors and patients must have already decided that a pallidotomy is the right treatment choice. The main goal is to see how safe the procedure is over two years. The study also aims to understand how this treatment might improve quality of life, movement, pain, speech, memory, and thinking abilities. There are plans for 10 participants, but the current recruitment status is unclear.

Study design: This is an interventional study with a planned enrollment of 10 participants. It is evaluating a device called ExAblate Transcranial MR guided Focused Ultrasound.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for two years to assess the incidence and severity of adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

NAAges 8–22InterventionalTreatment

Children's National Research Institute

~10 participants

Updated 2026-06-11 on ClinicalTrials.gov

What's tested:Focused Ultrasound Pallidotomy

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Incidence and severity of device-related and procedure-related adverse events (AE)

Measured over 2 years

Conditions

Cerebral Palsy, Dyskinetic

Secondary Dystonia

Where it's being run

1 sites across 1 states

District of Columbia1

Study leadership

Chima Oluigbo, MD · PRINCIPAL_INVESTIGATOR · Children's National Hospital, Washington, DC

Who to contact

Chima Oluigbo, MD

[email protected]

2024763531

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

Incidence and severity of device-related and procedure-related adverse events (AE)2 years
Safety will be determined by an evaluation of the incidence and severity of device-related and procedure-related adverse events (AE) from the first treatment day visit through the 24-month post-treatment time point. All AEs will be reported and categorized as related to the device versus the ablation procedure.

Trialytics