Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02097693 : Effect of DBS on Quality of Life in Dyskinetic Cerebral Palsy
PhaseN/A
AgesMin: 7 Years Max: 18 Years
Eligibility
Inclusion Criteria:

- 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 underaged 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 requirements, 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

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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02097693      |      Link to official Clinicaltrials.gov listing
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