Trials Sponsors Conditions Drugs Pricing

Conditions

Cerebral Palsy, Dyskinetic Secondary Dystonia

Keywords

High intensity focused ultrasound (HIFU)Pallidotomy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (16)

Burke-Fahn-Marsden-Dystonia Rating Scale movement and disability
2 years
Family Scale (FaBel)
2 years
Canadian Occupational Performance Measure (COPM)
2 years
Gross Motor Function Measure (GMFM-66)
2 years
Gross Motor Function Classification System (GMFCS)
2 years
+11 more secondary outcomes

Study Arms (1)

Focused Ultrasound Pallidotomy

EXPERIMENTAL

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

Device: Focused Ultrasound Pallidotomy

Interventions

Focused Ultrasound PallidotomyDevice

Use of ExAblate Transcranial MR guided Focused Ultrasound 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

Focused Ultrasound Pallidotomy

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age8 Years - 22 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

Children's National Research Institute
Otherlead

Study Sites (1)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Chima Oluigbo, MDCONTACT2024763531 coluigbo@childrensnational.org

Saige Teti, BACONTACT2024763020 sateti@childrensnational.org

MeSH Terms

Conditions

Cerebral PalsyDystonic Disorders

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement Disorders

Study Officials

Chima Oluigbo, MD
Children's National Hospital, Washington, DC
PRINCIPAL INVESTIGATOR

Central Study Contacts

Chima Oluigbo, MD

CONTACT

2024763531 coluigbo@childrensnational.org

Saige Teti

CONTACT

2024763755

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator and Sponsor

Study Record Dates

First Submitted

May 2, 2023

First Posted

September 13, 2023

Study Start

January 26, 2024

Actual (reported)

Primary Completion

August 2028

Estimated

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (16)

Study Arms (1)

Focused Ultrasound Pallidotomy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (16)

Study Arms (1)

Focused Ultrasound Pallidotomy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations