Effect of Deep Brain Stimulation in the Globus Pallidus internus on quality of life in young patients with dyston-dyskinetic Cerebral Palsy
- Conditions
- G80.3Dyskinetic cerebral palsy
- Registration Number
- DRKS00005797
- Lead Sponsor
- niversity of Cologne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
• The treating physician has chosen GPi-DBS for the treatment of the secondary dystonia caused by cere-bral palsy in this patient
• Patient and/or legal representative, if the patient is un-deraged or not capable to give consent himself, have chosen GPi-DBS as treatment
• The consent to participate in the trial of the underaged patient, if he is capable to understand the study re-quirements, is required
• Age at enrolment 7-18 years
• Diagnosis of secondary dystonia due to cerebral palsy caused by perinatal hypoxic injury
• Anti-dystonic pharmacotherapy insufficient (e.g. Jankovic J. Medical treatment of dystonia. Movement disorders, Vol. 28, No. 7, 2013) 67
• 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
• 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.
• Any previous brain surgery that would interfere with the placement of the leads or the functioning of the device.
• 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 <12 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 child bearing 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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in CPCHILD before and 12 months on DBS (response=improvement > 10%)
- Secondary Outcome Measures
Name Time Method Assensment of effect of bilateral GPi-DBS on<br>Dystonia<br>Spasticity<br>Dyskinesia<br>Motor function/disability<br>Pain<br>Cognition <br>Memory<br>Affection<br>Speech