Trial document





This trial has been registered retrospectively.
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  DRKS00008899

Trial Description

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Title

Electrophysiological characterization of pathological oscillations in Basal-Ganglia-Cortex-Loops and their coupling to muscle activity in patients with Idiopathic Parkinson's disease during the performance of a tapping task.

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Trial Acronym

InExPacT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this study we would like to investigate how the electrical activity of the brain is altered in Parkinson's patients compared to healthy controls. We use the recording of brain activity via an Electroencephalogramm (EEG) with 128 electrodes that are placed on the heads surface. At the same time, subjects are asked to perform a tapping task in which they either move their index finger synchronously to a given beat or they produce the before heard beat on their own. With this task, we investigate wether Parkinson's patients exhibit greater problems when producing self paced movements rather than externally triggered and wether these problems are accompanied by changes in the communication of brain areas.

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Brief Summary in Scientific Language

The idiopathic Parkinson’s syndrome is the second most common neurological disease in Germany. Across the country, about 100.000 to 200.000 people suffer from it. At the cellular level, the loss of dopaminergic neurons in the Substantia nigra pars compacta causes the cardinal neurological symptoms like Bradykinesia, Rigor, Tremor and postural instability.
New findings with respect to the development of motor symptoms in Parkinson’s disease suggest that the electrical activity of specific brain areas gets pathologically coupled. This hypothesis is based on non-invasive EEG and MEG recordings as well as synchronous recordings of muscle activity.
In the present study, we aim at recording EMGs from three forearm muscles as well as a 128-channel EEG form the head surface. Synchronously to electrophysiological recording, patients and healthy controls perform a finger tapping task consisting of three different conditions: a paced tapping condition were subjects were asked to tap in synchrony with an acoustic stimulus, a self-paced condition were the previously heard beat should be reproduced and a third condition were the acoustic stimulus was presented ten times and turned off afterwards while the rhythm should be maintained.
In previous studies it was shown that Parkinson’s patients perform worse compared to healthy controls in finger tapping tasks and that frequency specific coupling of lateral premotor cortex to supplementary motor area was missing. In addition, physiological coupling between the prefrontal cortex and premotor areas was absent in patients. The latter coupling could be reinstated by levodopa administration.
In the present study, we focus on the difference of externally and internally paced movements with respect to electrical coupling of motor related brain areas. We use a new class of mathematical models for inferring differences within a core motor network between Parkinson’s patients and healthy controls to investigate possible impairments with respect to rhythm generation that may be due to pathological alterations of coupling between brain areas.

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Organizational Data

  •   DRKS00008899
  •   2015/10/02
  •   [---]*
  •   yes
  •   Approved
  •   14-130, 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
  •   Healthy Subjects
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Interventions/Observational Groups

  •   healthy control subjects of the same age
  •   Parkinson's patients: EEG recording without medication in the state of bad mobility, "off"-state, standardized dose of dopaminergic drug (Madopar LT equivalent to the morning dose), repetition of the recording in the state of good mobility "on"-state
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Pathological coupling of motor related brain areas in Parkinson's patients compared to healthy subjects

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Secondary Outcome

Parkinson's patients exhibit a stronger impairment for self initiated than externally triggered movements.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/03/01
  •   24
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Healthy subjects:
• Male and female participants between 30 and 80 years of age
• Right handed persons
• Capability of signing an informed consent

Parkinson’s patients:
• Male and female patients with the diagnosis of an IPS according to the guidelines of the DGN
• Right handed patients
• positive motor response to L-Dopa or Apomorphine;
• Patients between 30 and 80 (in order to exclude genetic variants of the disease);
• time period of the symptomes longer than 4 years (differential diagnosis);
• patients have to be able to sign an informed consent;
• Ability to cooperate during the measurements

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Exclusion Criteria

Healthy subjects:
• non- "sui juris" patients, underaged persons as well as subjects which are judically sent to an institution
• diagnosis of an idiopathic parkinson syndrom or any other neurological disease
• participants that take drugs regularly which influence the nervous system and which can not be stopped the evening before the experiment
• severe internal comorbidities
• presence of psychiatric diseases
•impaired vision or hearing defect that may hinder the testing
• pregnant 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 severe frontal executive disturbances
• presence of a Parkinson-Plus-Syndrom like corticobasal degeneration, progressive supranuclear palsy or multisystem atrophy
• other hypokinetic movement disorders like MPTP- or manganese intoxication, chorea Huntington, subcortical arteriosclerotic encephalopathy or psychogenic movement disorder
• clinically relevant abnormalities in preoperative MR-Images like ischemia, or cerebral athropy
• previous surgeries in the ZNS due to, for example, brain tumors, epilepsy or vascular reasons
• severe internal comorbidities
• presence 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 PsychiatrieUniklinikum 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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    • AG für Bewegungsstörungen und Tiefe HirnstimulationKlinik und Poliklinik für Neurologie und PsychiatrieUniklinikum Köln
    • Ms.  Dr. rer. nat.  Fabienne  Jung 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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    • Uniklinik Köln, AG für Bewegungsstörungen und Tiefe Hirnstimulation
    • Ms.  Dr. rer. nat.  Fabienne  Jung 
    • Kerpener Straße 62
    • 50924  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 ongoing
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Trial Publications, Results and other Documents

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