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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Children's National Research Institute
Study ID
NCT06036199
Status
Recruiting
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Conditions

  • Cerebral Palsy, Dyskinetic
  • Secondary Dystonia

Eligibility Criteria

Sex
ALL
Age
8 Years - 22 Years
Healthy Volunteers
Not accepted

Interventions

  • Focused Ultrasound Pallidotomy — DEVICE
    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

Study Details

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

Key Dates

Start date
Jan 26, 2024
Status verified
Apr 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Focused Ultrasound Pallidotomy
    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

Primary Outcome Measure

Incidence and severity of device-related and procedure-related adverse events (AE) [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's National HospitalWashington D.C.District of Columbia20010
Chima Oluigbo, MD
[email protected]
2024763531
Saige Teti, BA
[email protected]
2024763020

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By research site
Children's National Hospital· Washington D.C., DC

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