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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06036199
Other study ID # G230044
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 26, 2024
Est. completion date August 2025

Study information

Verified date February 2024
Source Children's National Research Institute
Contact Chima Oluigbo, MD
Phone 2024763531
Email coluigbo@childrensnational.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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. The secondary is to assess the impact on Quality of Life of Focused Ultrasound Bilateral and unilateral Pallidotomy for Dyskinetic Cerebral Palsy in Pediatric and Young Adult Subjects. In addition, the impact of bilateral pallidotomy on motor development, pain perception, speech, memory, attention and cognition in these patients will also be assessed.


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Study Design


Intervention

Device:
Focused Ultrasound Pallidotomy
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

Locations

Country Name City State
United States Children's National Hospital Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Children's National Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Burke-Fahn-Marsden-Dystonia Rating Scale movement and disability Assessment of speech and swallowing. Score range: 0-30, 0 indicates complete independence, 30 indicates complete dependence. 2 years
Secondary Family Scale (FaBel) Assessment of the burden for caregivers. Score range: 0-84, 0 indicates no burden, 84 indicates very severe burden. 2 years
Secondary Canadian Occupational Performance Measure (COPM) Assessment of activities of daily living. 2 years
Secondary Gross Motor Function Measure (GMFM-66) Assessment of physical disability. Score range: 0-3, 0 indicates no performance, 3 indicates complete performance. 2 years
Secondary Gross Motor Function Classification System (GMFCS) Degree of physical impairment. Score range: 1-5, 1 indicates no limitations, 5 indicates severe limitations. 2 years
Secondary SF-36 for assessment of quality of life Assessment of quality of life of subject. Score range: 0-100, 0 indicates bad health state, 100 indicates an excellent health state. 2 years
Secondary Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) Assessment of Quality of life of Caregivers and Subject. Score range: 0-100, 0 indicates a bad score, 100 indicates an excellent score. 2 years
Secondary Frenchay Dysarthria Assessment Assessment of speech and swallowing. Score range: 2 years
Secondary Assessment of Cognition Snijders-Oomen-Non-Verbal-Intelligence Test (SON-R) 2 years
Secondary Strengths and Difficulties Questionnaire Assessment of mood and attention. Score range: 0-40, 0 indicates normal, 40 indicates abnormal. 2 years
Secondary Assessment of Attention Attentional Network Test (ANT) 2 years
Secondary Assessment of cognition Non-Verbal-Learning Test (NVLT) 2 years
Secondary Wong Baker Faces Assessment of pain. Score range; 0-10, 0 indicates no pain, 10 indicates worst pain. 2 years
Secondary Tardieu Scale Assessment of the severity of spasticity. Score range: 0-5, 0 indicates no resistance, 5 indicates no movement. 2 years
Secondary Dyskinesia Impairment Scale (DIS) Assessment of the severity of chorea and dystonia. Score range: 0-576, 0 indicates no dystonia, 576 indicates very severe dystonia. 2 years
Secondary Barry Albright Dystonia Scale Score range: 0-32, 0 indicates no dystonia, 32 indicates severe dystonia. 2 years
See also
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Completed NCT06307561 - The Effect of Dystonia Severity on Participation in Daily Living Activities and Caregivers in Children of Cerebral Palsy With Secondary Dystonia
Completed NCT03347240 - Neuroablation Versus Neuromodulation Techniques for Treatment of Secondary Dystonia N/A