Trial document





This trial has been registered retrospectively.
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  DRKS00014966

Trial Description

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Title

Multi Recharge Trial

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Trial Acronym

MR

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Since roughly 10 years rechargeable neurostimulators for deep brain stimulation are available. These stimulators need to be regularly checked and charged by the patient, to provide continuous therapy. This study is meant to document and rate the patients' experience with this technology. This study is a questionnaire study with complication assessment by the implanting hospitals.

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Brief Summary in Scientific Language

Prospective, multicentric, study with retrospective data analysis via patient questionnaire and database analysis with regards to rechargeable neurostimulators for deep brain stimulation in movement disorder patients.

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Organizational Data

  •   DRKS00014966
  •   2018/06/26
  •   [---]*
  •   yes
  •   Approved
  •   S-312/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   G20 -  Parkinson disease
  •   G25 -  Other extrapyramidal and movement disorders
  •   G24 -  Dystonia
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Interventions/Observational Groups

  •   All adult patients with movement disorders who received a rechargeable neurostimulator during primary implantation or during a neurostimulator exchange.
    Being a retrospective data analysis all patients that fit the inclusion criteria receive a questionnaire. This questionnaire asks the patient about their experience and problems with rechargeable neurostimulators and allows them to assess the recharging process. Filing the questionnaire takes roughly 15 minutes.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   IV
  •   N/A
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Primary Outcome

Assessment or recharging (utilizing a semiquantitative score in the questionnaire at the time of the query)

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Secondary Outcome

Type and rate of complication from implantation to time of query.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2018/01/01
  •   280
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Implantation of a rechargeable neurostimulator for deep brain stimulation to treat movement disorders. Comparison of primary and secondary implanted patients. Comparison of different neurostimulator models.

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Exclusion Criteria

Non-rechargeable Neurostimulator.
Inability to give informed consent.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum HeidelbergNeurochirurgische Klinik
    • Mr.  Dr. med.  Martin  Jakobs 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Schleswig-HolsteinUniversitätsklinikum KielNeurochirurgische Klinik
    • Ms.  Dr. med.  Ann-Kristin  Helmers 
    • Arnold-Heller-Straße 3
    • 24105  Kiel
    • Germany
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    • Universitätsklinikum RegensburgNeurochirurgische Klinik
    • Ms.  Dr. med.  Judith  Anthofer 
    • Franz-Josef-Strauß-Allee 11
    • 93053  Regensburg
    • Germany
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    • Universitätsklinikum DüsseldorfNeurochirurgische Klinik
    • Mr.  PD Dr. med.  Philipp  Slotty 
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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    • Universitätsklinikum HeidelbergNeurochirurgische Klinik
    • Mr.  Dr. med.  Martin  Jakobs 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum HeidelbergNeurochirurgische Klinik
    • Mr.  Dr. med.  Martin  Jakobs 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum HeidelbergNeurochirurgische Klinik
    • Mr.  Dr. med.  Martin  Jakobs 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/12/31
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Trial Publications, Results and other Documents

  •   Ethikvotum Heidelberg
  •   Prüfplan
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* This entry means the parameter is not applicable or has not been set.