Trial document





This trial has been registered retrospectively.
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  DRKS00006778

Trial Description

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Title

Deep brain stimulation before the age of 18 in patients with childhood-onset dyskinetic movement disorders - a German registry for quality assurance

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Trial Acronym

GEPESTIM

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URL of the Trial

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Brief Summary in Lay Language

Deep brain Stimulation (DBS) has proven to be a safe and effective therapy for primary dystonia. The results in patients with aquired dystonia are variable.
So far there is only little data about the effect of deep brain stimulation on movement disorders in paediatric patients. With the the registry all available data of patients with a childhood-onset dyskinetic movement disorder who received DBS before the age of 18 years should be collected. The pre-, peri- and postoperative data encompass medical history of the patients, etiology of disease, evolution of symptoms, pharmacotherapy and supportive therapy, technical details of the DBS implantation, stimulation parameters and complications.
The analysis of this data should help to evaluate the effect of DBS comprehensively and to identify possible outcome predictors in order to improve counselling of affected families and to select suitable patients. Furthermore, treatment standards should be created to optimize the service of young patients undergoing DBS.

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Brief Summary in Scientific Language

Deep brain Stimulation (DBS) has proven to be a safe and effective therapy for primary dystonia. The results in patients with secondary dystonia are heterogeneous.
So far there is only little data about the effect of deep brain stimulation (DBS) on movement disorders in paediatric patients. With the the registry all available data of patients with a childhood-onset dyskinetic movement disorder who received DBS before the age of 18 years should be collected. The pre-, peri- and postoperative data encompass medical history of the patients, etiology of disease, evolution of symptoms, pharmacotherapy and supportive therapy, technical details of the DBS implantation, stimulation parameters and complications.
The analysis of this data should help to evaluate the effect of DBS comprehensively and to identify possible outcome predictors in order to improve counselling of affected families and to select suitable patients. Furthermore, treatment standards should be created to optimize the service of young patients undergoing DBS.

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Organizational Data

  •   DRKS00006778
  •   2014/12/01
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  •   yes
  •   Approved
  •   13-168, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   G80.3 -  Dyskinetic cerebral palsy
  •   G24.1 -  Idiopathic familial dystonia
  •   G23.0 -  Hallervorden-Spatz disease
  •   E79.1 -  Lesch-Nyhan syndrome
  •   G24.2 -  Idiopathic nonfamilial dystonia
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Interventions/Observational Groups

  •   With the aid of the registry data of patients with a childhood-onset dyskinetic movement disorder who received DBS before the age of 18 years should be systematically collected encompassing information on medical history of the patients, disease etiology, evolution of symptoms, pharmacotherapy, supportive therapy, technical details of DBS implantation, stimulation parameters and complications.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Change of Burke-Fahn-Marsden Dystonia Rating Scale after Deep Brain Stimulation

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Secondary Outcome

Deep Brain Stimulation effect on - dystonia - dyskinesia - pain - memory - affect - quality of life - spasticity - motor function - cognition - attention - speech

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2013/10/14
  •   60
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

- Diagnosis of childhood-onset dyskinetic movement disorders
- Deep brain stimulation before the age of 18

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Exclusion Criteria

- No diagnosis of childhood-onset dyskinetic movement disorders
- Deep brain stimulation after the age of 18

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Addresses

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    • University of Cologne
    • Albertus-Magnus-Platz
    • 50923  Cologne
    • Germany
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    • Uniklinik Köln Neurologie
    • Mr.  Univ.-Prof.  Lars  Timmermann 
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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    • Uniklinik Köln Neurologie
    • Ms.  Dr.  Anne  Koy 
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Univerität zu Köln
    • Intramurale Finanzierungsquelle 
    • Albertus-Magnus-Platz
    • 50925   Köln
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.