Trial document





This trial has been registered retrospectively.
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  DRKS00005635

Trial Description

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Title

Functional and effective connectivity of motor areas in parkinsons patients in comparision to healthy subjects belonging to two different groups of age.

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Trial Acronym

BiSyT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In the study here presented we intend to investigate brain activity of healthy subjects belonging to two groups of age and compare the findings to the pathological processing in the brain of Parkinson's patients.
With this study it should be evaluated how normal aging modifies processing in the brain and, in addition, investigated how the information processing is changed in patients with Parkinson's disease.
Furthermore, a detailed evaluation of the effect of dopamine replacement therapy usind L-dopa will be conducted.

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Brief Summary in Scientific Language

The goal of the study here presented is the characterisation of functional and effective connectivity of motor areas (primary motor cortex (M1), supplementary motor area (SMA), premotor cortex (PMC), and prefrontal cortex (PMC)) as well as the cerebellum during the conduction of a complex bimanual tapping tast.
We intend a comparison of the connectivities found for a young and an old group of healthy participants with a group of Parkinson's patients. Another major point of this study is the investigation of the effect of dopamine replacement therapy with L-dopa on the detected functional and effective connectivities in the brain of parkinsons patients.

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Organizational Data

  •   DRKS00005635
  •   2014/03/11
  •   [---]*
  •   yes
  •   Approved
  •   13-394, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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

  •   G20 -  Parkinson disease
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Interventions/Observational Groups

  •   young, healthy subjects (128-channel EEG-recording during the performance of a tapping-task)
  •   old, healthy subjects (128-channel EEG-recording during the performance of a tapping-task)
  •   Parkinson's patients (128-channel EEG-recording during the performance of a tapping task without L-dopa medication ("off" condition) and with L-dopa medication ("on" condition)
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment, Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Pathological coupling of motor areas depending on the complexity of a Tapping-task in Parkinson's patients.

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Secondary Outcome

Prediction of behavioral errors during the performance of a Tapping-task in Parkinson's patients.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/02/10
  •   72
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Healthy subjects:

• male and female paticipants, age 20 to 40 mother language: german
• male and female paticipants, age 50 to 70, mother language: german
• capability of signing an informed consent

Parkinson's patients:
• male and female patients with the clinical diagnosis of an idopathic parkinson syndrom
• age between 40 and 80, motherlangue: german
• capability of signing an informed consent

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Exclusion Criteria

Healthy participants:
• diagnosis of an idiopathic parkinson syndrom or any other neurological disease
• participants with a contraindication for an MR-scan like metal parts inside the body, i.e. cardiac pacemaker, stents etc.
• participants that take drugs regularly which influence the nervous system and which can not be stopped the evening befor the experiment
• pragnent or breast feeding mothers

Parkinson's patients:
• non- "sui juris" patients, underaged persons as well as subjects which are judically sent to an institution
• patients that suffer from another neurological disease apart from Parkinsons like Epilepsy, Alzheimers or Dystonia
• patients with claustrophobia
• participants with a contraindication for an MR-scan like metal parts inside the body, i.e. cardiac pacemaker, stents etc.
• patients with irregular MR-scans like ischemia, cerebral atrophy etc.
• former surgeries on the head especially for the implantation of electrodes for Deep Brain Stimulation Therapy
• pronounced head tremor that does not allow laying still in the MR and produces artefacts during EEG recordings
• presense of psychiatric diseases
• impaired vision or hearing defect that may hinder the testing
• pregnant or breast feeding mothers

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Addresses

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    • AG für Bewegungsstörungen und Tiefe HirnstimulationKlinik und Poliklinik für Neurologie und Psychiatrie Uniklinikum Köln
    • Mr.  Prof. Dr. med.  Lars  Timmermann 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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    •   0221-4787494
    •   0221-47887512
    •   [---]*
    •   [---]*
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    • Uniklinik Köln, NeurologieArbeitsgruppe für Bewegungsstörungen und Tiefe Hirnstimulation
    • Mr.  Prof. Dr. med.  Lars  Timmermann 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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    • Uniklinik Köln, NeurologieArbeitsgruppe für Bewegungsstörungen und Tiefe Hirnstimulation
    • Ms.  Elfriede  Stubbs 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/07/31
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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.