Sound waves aim to calm uncontrollable movements in kids with cerebral palsy
NCT ID NCT06036199
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a non-invasive sound wave procedure (focused ultrasound) can safely improve movement and quality of life in 10 children and young adults (ages 8-22) with dyskinetic cerebral palsy. The treatment targets a small area in the brain to reduce involuntary movements. Researchers will track side effects and measure changes in movement and caregiver burden over 24 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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8 to 22 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * The consent to participate in the trial of the underaged patient, if he is capable to understand the study requirements, is required * Age at enrolment 8-22 years * Diagnosis of secondary dystonia due to cerebral palsy caused by perinatal hypoxic injury * Anti-dystonic pharmacotherapy insufficient * Stable anti-dystonic medication over the last 30 days * Globus pallidus internus (pars posterior) and thalamus (motor part) intact on MRI (not older than 2 years - if possible) * No fixed severe skeletal deformations with loss of function, which need immediate orthopaedic surgical intervention * Sufficient compliance of the patient or the legal representative if the patient is underaged or not capable to give consent himself to take part in the study * Informed consent to take part in the study from patient and/or legal representative if the patient is underaged or not capable to give consent himself * 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 Exclusion Criteria: * Patients with known primary (e.g. DYT1) or idiopathic dystonia * Severe axial hypotonia with total loss of head control (e.g. absence of control at "upper thoracic level" in the SATCo score) (medication effect excluded) * Fixed hemi-dystonia * Severe spasticity in knee- and elbow-flexors and -extensors (Modified Ashworth Scale \>3) * Fixed severe skeletal contractions with loss of function which require immediate orthopaedic surgical intervention * Patients with other severe concurrent neurological disease (e. g. brain tumor, neurodegenerative diseases, trauma etc.) * Condition likely to require use of MRI in the future * Any intracranial abnormality or medical condition that would contraindicate DBS surgery * Any findings in neuropsychological screening assessments that would contraindicate DBS surgery * Any current drug and / or alcohol abuse * Any history of frequent grand-mal seizures without response to anticonvulsive treatment * Any other active implanted device (e.g. Cochlear implant, pacemaker), whether turned on or off, would be allowed provided that they do not interfere with functioning of the device. * The presence of DBS leads due the risks of these ferromagnetic devices in the MRI environment. * A history of neurostimulation intolerance in any area of the body. * Currently on any anticoagulant medications that cannot be discontinued during perioperative period. * Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival \<24 months. * Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days; any other trial participation should be approved by the Principal Investigator. * A female that is breastfeeding or of childbearing potential with a positive urine pregnancy test or - if a person is sexually active - not using sufficient contraception with a Pearl Index of less than 1% including all forms of hormonal contraception ("antibaby-pill", hormonal plaster, NuvaRing®, Implanon®, hormonal depot injections, contraceptive coil), the tubal ligature (female sterilization). Alternatively, the female of child bearing potential is sexually abstinent. * Subjects who have contraindications to anesthesia, in the judgment of the attending anesthesiologist * Subjects who are unwilling or unable to undergo general anesthesia * Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data. * Minimum head circumference \< 49cm * Skull Density Ratio (SDR) \<0.40.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's National Hospital
RECRUITINGWashington D.C., District of Columbia, 20010, United States
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Other studies related to the condition(s) this trial covers.
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- Brain stimulation study probes Cerebellum's role in dystonia