Effect of DBS on Quality of Life in Dyskinetic Cerebral Palsy

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.
• •* 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.