Is NCT06036199 recruiting in Washington Dc, DC?

Yes, NCT06036199 is currently recruiting participants at its Washington Dc, DC location. This cerebral palsy, dyskinetic clinical trial is actively enrolling qualified participants.

How do I join the cerebral palsy, dyskinetic clinical trial in Washington Dc?

To join this clinical trial in Washington Dc, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Washington Dc clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Cerebral Palsy, Dyskinetic Clinical Trial in Washington Dc, DC

About This Cerebral Palsy, Dyskinetic Study in Washington Dc

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

Sponsor: Children's National Research Institute

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Washington Dc?

Yes, this clinical trial (NCT06036199) has an active research site in Washington Dc, DC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Cerebral Palsy, Dyskinetic Treatment Options in Washington Dc, DC

If you're searching for cerebral palsy, dyskinetic treatment options in Washington Dc, DC, this clinical trial (NCT06036199) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Washington Dc research site is actively enrolling participants for this clinical trial. You'll receive care from experienced cerebral palsy, dyskinetic specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all cerebral palsy, dyskinetic clinical trials near you to find additional studies recruiting in your area.

Cerebral Palsy, Dyskinetic Clinical Trial in Washington Dc, DC

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