Trial document





This trial has been registered retrospectively.
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  DRKS00003137

Trial Description

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Title

Networkmodulation in Dystonia patients with Globus pallidus deep brain stimulation with H2O-PET

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Trial Acronym

DYSTO-PET

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URL of the Trial

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Brief Summary in Lay Language

Dystonia is a disease of the motor systems with inclusion of different body parts and different progression of the disease.
One therapy option is the recently developed deep brain stimulation which modulates the affected brain motor network in a way which improves symptoms of dystonia. The mechanisms of deep brain stimulation are so far not completely understood.
This study aims to show different patterns of blood flow during a motor task with a simple finger movement in patients with and without deep brain stimulation compared to healthy controls. A special focus is to have a closer look on a not affected hand.
We want to show in this study if during the use of an unaffected hand changes in the blood flow can be observed and which effects has the deep brain stimulation on the motor network in dystonia.

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Brief Summary in Scientific Language

Dystonia is a disease of the motor systems with inclusion of different body parts and different progression of the disease. The mechanisms of the development of different symptoms from a single affected segment to a generalisation are not known yet. Especially the question of bilateral functional sensorimotor abnormalities in unilateral affected patients are not understood.
One therapy option is the recently developed deep brain stimulation in the globus pallidus internus which modulates the affected brain motor network in a way which improves symptoms of dystonia. The mechanisms of deep brain stimulation are so far not completely understood.
This study aims to show different patterns of blood flow with H2O-positronemissiontomography during a motor task with a simple finger movement in patients with and without deep brain stimulation compared to healthy controls. A special focus is to have a closer look on a not affected hand with electromyography (EMG).
We want to show in this study if during the use of an unaffected hand changes in the blood flow can be observed and which effects has the deep brain stimulation on the motor network in dystonia.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00003137
  •   2011/10/18
  •   [---]*
  •   yes
  •   Approved
  •   08-246, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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

  •   G24 -  Dystonia
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   Patients with dystonia without deep brain stimulation

    Examination:
    H2O-positron emission tomography (PET) with active and passive finger movement and simultaneous EMG-recording at one timepoint
  •   Patients with dystonia with deep brain stimulation

    Examination:
    H2O-positron emission tomography (PET) with active and passive finger movementand simultaneous EMG-recording at one timepoint
  •   Healthy controls

    Examination:
    H2O-positron emission tomography (PET) with active and passive finger movement and simultaneous EMG-recording at one timepoint
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   [---]*
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Primary Outcome

changes in the blood flow in H2O-PET between the following conditions/groups:
1. patients in the rest-condition with and without deep brain stimulation
2. patients in the rest-condition with and without dystonia
3. patients with dystonia and deep brain stimulation in the active and passive movement condition

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Secondary Outcome

Changes in the muscular oscillations in the EMG in the following conditions/groups:
1. patients in the rest-condition with and without deep brain stimulation
2. patients in the rest-condition with and without dystonia
3. patients with dystonia and deep brain stimulation in the active and passive movement condition

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2010/06/01
  •   36
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

- male or female patients with cervical or segmental dystonia with or without deep brain stimulation in the globus pallidus internus
- diagnosis has to be confirmed with the clinical course and a neurological examination
- dystonia has to be bearable after switching the deep brain stimulation

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Exclusion Criteria

- no preoperative coregistered cranial magnetresonancetomography in case of patients with deep brain stimulation
- patients with other neurological disorders (e.g. epilepsia, stroke, Alzheimer's dementia)
- life-threatening diseases
- severe psychiatric disorders
- obvious premorbid mental deficits
- pregnant women

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Uniklinik Köln Klinik für Neurologie
    • Mr.  Prof. Dr.   Lars  Timmermann 
    • Kerpener Str. 62
    • 50931  Köln
    • Germany
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    • Uniklinik Köln Klinik für Neurologie
    • Mr.  Prof. Dr.   Lars  Timmermann 
    • Kerpener Str. 62
    • 50931  Köln
    • Germany
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    • Uniklinik Köln Klinik für Neurologie
    • Mr.  Prof. Dr.   Lars  Timmermann 
    • Kerpener Str. 62
    • 50931  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Köln Klinik für Neurologie
    • Mr.  Prof. Dr.   Lars  Timmermann 
    • Kerpener Str. 62
    • 50931  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/05/31
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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.