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Procedure

Focused Ultrasound Pallidotomy for Cerebral Palsy

N/A

Recruiting

Led By Chima Oluigbo, MD

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No fixed severe skeletal deformations with loss of function, which need immediate orthopaedic surgical intervention

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

Must not have

Any intracranial abnormality or medical condition that would contraindicate DBS surgery

Subjects who are unwilling or unable to undergo general anesthesia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to assess the safety of using ExAblate Transcranial MRgFUS to create lesions in the globus pallidus in patients with treatment-resistant secondary dystonia caused by

Who is the study for?

This trial is for young individuals aged 8-22 with secondary dystonia due to cerebral palsy caused by perinatal hypoxic injury. They should have tried other medications without enough benefit and be considered for pallidotomy or GPi-DBS by their doctor. Participants need stable medication for the last month, an intact globus pallidus on MRI, no severe skeletal deformations requiring surgery, and must consent to the study.

What is being tested?

The trial tests ExAblate Transcranial MRgFUS's safety in creating lesions within a brain region called the globus pallidus. This non-invasive procedure aims to alleviate treatment-resistant dystonic movements in patients with dyskinetic cerebral palsy.

What are the potential side effects?

While specific side effects are not listed here, focused ultrasound procedures like this one may cause discomfort at the site of treatment, headache, nausea or dizziness during or after the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have severe bone deformities that require urgent surgery.

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I, or my legal guardian, understand the study and have given written consent.

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My dystonia is due to cerebral palsy from a lack of oxygen at birth.

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I or my legal guardian have chosen pallidotomy as my treatment.

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I am between 8 and 22 years old.

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My current medication for muscle control issues is not effective.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have brain conditions that prevent DBS surgery.

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I cannot or do not want to have general anesthesia.

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I do not have severe brain conditions like tumors or Alzheimer's.

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I am taking blood thinners that can't be stopped for surgery.

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My mental health screening does not prevent me from having DBS surgery.

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I frequently have grand-mal seizures that don't improve with medication.

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I need surgery soon for severe joint stiffness that stops me from moving properly.

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I have been diagnosed with a specific type of muscle disorder, such as DYT1 dystonia.

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I cannot control my head due to severe muscle weakness.

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I have severe stiffness in my knees and elbows (high score on a stiffness scale).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Assessment of Attention

Assessment of Cognition

Assessment of cognition

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Focused Ultrasound PallidotomyExperimental Treatment1 Intervention

Pediatric and young adult patients between ages of 8 and 22 years with pharmaco-resistant secondary dystonia due to dyskinetic cerebral palsy who have Focused Ultrasound Pallidotomy

0 / 16Eligibility criteria met