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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Assessment of Attention

Assessment of Cognition

Assessment of cognition

+13 more

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 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor

211 Previous Clinical Trials

208,147 Total Patients Enrolled

2 Trials studying Cerebral Palsy

300 Patients Enrolled for Cerebral Palsy

Chima Oluigbo, MDPrincipal InvestigatorChildren's National Hospital, Washington, DC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical study allow individuals who are at least 18 years old to participate?

"The study seeks participants aged over 8 years and under 22 years."

Answered by AI

Which specific criteria determine the eligibility of individuals for participation in this clinical trial?

"This research project seeks to enroll 10 individuals aged between 8 and 22 with cerebral palsy. Interested candidates must meet specific requirements: The patient or their legal guardian, if the patient lacks capacity to provide consent, have chosen pallidotomy as a treatment option; inadequate response to anti-dystonic pharmacotherapy; the treating physician has recommended GPi-DBS or pallidotomy for secondary dystonia due to cerebral palsy in this particular case; assent from capable underaged patients is mandatory if they comprehend study obligations; age requirement of 8-22 years at enrollment; diagnosis of secondary dystonia stemming from perinatal"

Answered by AI

Are there any vacancies available for patients to participate in this trial?

"As indicated on clinicaltrials.gov, this research is actively seeking eligible participants. The initial posting date of the trial was January 26th, 2024 and the most recent update occurred on February 8th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Chima Oluigbo 2024. "Focused Ultrasound Pallidotomy for Dyskinetic Cerebral Palsy in Pediatric and Young Adult Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06036199.

All > Dystonia > Cerebral Palsy