Trial document




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  DRKS00006257

Trial Description

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Title

Neuronal osciallations in basal-ganglia-loops and their therapeutic modulation in patients with idiopathic Parkinson syndrome.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In the study here presented we investigate how information processing in the brain is disturbed in Parkinson’s patients. Today, it is known that pathologically altered electrical activity leads to the core, motor symptoms of the disease. Thereby, the activity of several brain areas in the motor system becomes coupled and the natural interaction gets disturbed. In the current study we aim to measure the electrical brain activity of Parkinson’s patients as an electroencephalogram (EEG) as well as the activity of forearm muscles during defined movements. In addition to the experiments before and after the implantation of electrodes for deep brain stimulation (DBS), recordings will be performed during surgery. For answering scientific questions, DBS offers the unique possibility to measure neuronal activity in deep brain areas during electrodes implantation.
With the above described measurements and the use of new mathematical analysis tools, we are able to characterize the interplay between brain areas and muscles that leads to movements. The deeper understanding of pathological mechanisms may lead to the development of better treatments for Parkinson’s disease and, moreover, to a better adjustment of the therapy to subtypes of the disease and thereby individual patient.

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Brief Summary in Scientific Language

The idiopathic Parkinsons-Syndrome is characterized by four cardinal motor symptoms, namely bradykinesia, rigor, tremor and postural instability. At the cellular level, it is accompanied by a loss of dopaminergic cells in the substantia nigra pars compacta. Today, it is known that pathologically altered oscillatory electrical activity in brain motor areas leads to the core, motor symptoms of the disease.
As symptomatic therapy, L-Dopa as well as dopamine agonists are used, and, as a secondary option, these drugs are combined with deep brain stimulation (DBS). DBS in the subthalamic nucleus reduces motor symptoms likewise dopaminergic medication, and improves the patient’s quality of life.
In the study here described, activity of motor areas is recorded with a 128-channel-EEG-system from the head surface together with temporally synchronized muscle activity recorded from the right forearm with EMG during defined, simple movements. In addition to these measurements, that will be conducted pre- and postoperatively (three days and three months after surgery), electrophysiological activity in deep brain structures is recorded. The surgery for implantation of DBS electrodes offers the unique possibility to detect activity in the target structures.
The subsequent mathematical analysis of the detected signals enables us to further investigate the pathological information processing in the brain of Parkinson’s patients and may lead to a deeper understanding of the effectiveness of DBS. Furthermore, the motor network of patients should be further investigated. The recording of several temporally synchronized electrophysiological parameters (EEG, EMG, LFP and spikes) allows an extensive characterization of motor loops. Recordings with and without L-Dopa-therapy permits the analysis of therapeutically modified activity and a correlation with the overall clinical outcome. Due to measurements of the same patients at different points in time (pre-, intra-, postoperatively and after 3 month) the progression of the disease can be investigate.

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Organizational Data

  •   DRKS00006257
  •   2014/07/08
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  •   yes
  •   Approved
  •   14-129, 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

  •   healthy volunteers, age-matched
    (EEG recording with a 128-channel-system from the head surface and synchronous measurment of the EMG from the right forearm during the conduction of simple movments)
  •   Parkinsons-Patients
    (pre- and posteroperatively EEG-recording with a 128 channel system from the head surface, synchronous recording of the EMG from the right forearm during the conduction of simple movements; intraoperatively: the above mentioned electrophysiological measurements will be accompanied by the recording of local field potentials as well as single cell activity from the target structures of deep brain stimulation using microelectrodes; perioperatively, in addition to EEG and EMG, local field potentials will be recorded by the use of externalized electrodes)
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Pathological, oscillatory coupling between EEG and EMG in the beta range (13-30 Hz) on different measurement days without treatment

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Secondary Outcome

Comparision of pathological, electrophysiological acitivity for two Parkinsons-Subtypes (tremor-dominant versus akinetic rigid)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/08/01
  •   48
  •   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
• Patients with the indication for receiving deep brain stimulation (target areas: STN, GPi, Vim) with uncontrollable motor symptomes due to strong dyskinesia and/ or ON/OFF fluctuations
• 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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    • Uniklinik Köln, NeurologieArbeitsgruppe für Bewegungsstörungen und Tiefe Hirnstimulation
    • Mr.  Prof. Dr. med.  Lars  Timmermann 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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    • Klinik und Poliklinik für NeurologieArbeitsgruppe Bewegungsstörungen und Tiefe Hirnstimulation
    • Ms.  Dr. rer. nat.  Fabienne  Jung 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Klinik und Poliklinik für NeurologieArbeitsgruppe Bewegungsstörungen und Tiefe HirnstimulationStudienbüro
    • Elfriede  Stubbs 
    • Kerpener Str. 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 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.