DRKS00005797招募中不适用
Effect of Deep Brain Stimulation in the Globus Pallidus internus on quality of life in young patients with dyston-dyskinetic Cerebral Palsy - STIM-CP
niversity of Cologne0 个研究点目标入组 20 人开始时间: 2014年4月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 7 Years 至 18 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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.
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