Trial document




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  DRKS00011207

Trial Description

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Title

Detection of central pain processing in patients with Parkinsons's disease

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Trial Acronym

LEP Parkinson

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Patients with Parkinson's disease suffer from pain more often than others at the same age. This pain may occur years before the regular symptoms of Parkinson's disease onset. Additionally, these patients often do not receive adequate pain-therapy in comparison to people without Parkinson's disease. They often suffer from more than one type of pain. In some cases these pain symptoms result from constrainded movement ability. If patients suffer from nerval ache, in approximately 10% of all cases no reason for this pain is found. It is believed that this kind of pain originates in the brain. In most cases, one body site is more affected than the other.
An enduring Parkinson's disease is accompanied by degeneration of brain cells. It is assumed that Parkinson's disease may also contribute to impaired central pain processing.

The main aim of this exploratory study is:

Patients with Parkinson's disease show different patterns of central pain processing as compared to healthy controls.

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Brief Summary in Scientific Language

Patients with Parkinson's disease suffer from pain more often than others at the same age. This pain can occur years before the classic symptoms of Parkinsons disease (rigor, tremor, akinesia, postural instability) as a non-motor symptom.
In many cases it is not noticed as an early sign of Parkinson's disease. Additionally, these patients receive sufficient pain therapy less often than patients with other diseases. A problem is that patients with Parkinson's disease often suffer from more than one type of pain.
For approximately 10% of patients with Parkinson’s disease who suffer under neuropathic pain, no explanation for this pain can be found. It is therefore assumed that it has its origin in the central nervous system.
In addition, the side which is stronger affected by the motor symptoms of Parkinson's disease is also stronger affected by this neuropathic pain.
Parkinson's disease is a neurodegenerative disease. It is assumed that Parkinson's disease may also contribute to impaired central pain processing.

The main aim of this exploratory study is:

Patients with Parkinson's disease show different patterns of central pain processing as compared to healthy controls.

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Organizational Data

  •   DRKS00011207
  •   2017/01/10
  •   [---]*
  •   yes
  •   Approved
  •   D532/16, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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

  •   G20.9 -  [generalization G20: Parkinson disease]
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Interventions/Observational Groups

  •   Patients with Parkinson's disease and pain; Testing for abnormal central pain processing;
    We want to compare the patients and contol persons by using laser evoked potentials. These potentials will be created at the location of the main pain of the patients.
    We are searching for different central pain processing between the three groups.
  •   Patients with Parkinson's disease without pain; Testing for abnormal central pain processing
  •   age - matched normal persons; Testing for abnormal central pain processing
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The main aim of this study is the detection of abnormal central pain processing in patients with Parkinson's disease

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Secondary Outcome

Differentiation between painful and painless PD syndromes regarding central pain processing

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2017/02/01
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1) legal competence of the study participants (MOCA > 18), signed informed consent
2) ability to adequate communication and editing of the used questionnaires
3)
a) clinical signs of Parkinson's disease at stadium Hoehn and Yahr 2 - 3
b) abnormal sniffing sticks test
c) hyperechoic substantia nigra at transcranial ultrasonic examination at least at one side (with sufficient ultrasound window); in addition no sign of a secondary or atypical parkinson syndrome
4) in the painful group no other explanation for the occurence of pain is found

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Exclusion Criteria

1) abuse of alcohol, illegal drugs or medicine in the past (or suspect of the tester)
2) known other neurologic disease, which leads to different sensoric sensation
3) pregnancy and lactation period
4) members of family of the testers
5) membership in an other study for the last four weeks befor the recruitment visit
6) therapy with strong analgesics (WHO -3)

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Addresses

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    • Universitätsklinikum Schleswig-Holstein Campus Kiel
    • Arnold-Heller-Str. 3
    • 24105  Kiel
    • Germany
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    • Klinik für Neurologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel
    • Mr.  Dr.  Philipp  Hüllemann 
    • Arnold-Heller-Str. 3
    • 24105  Kiel
    • Germany
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    • Klinik für Neurologie, Universitätsklinikum Schleswig-Holstein Campus Kiel
    • Mr.  Dr.  Philipp  Hüllemann 
    • Arnold-Heller-Str. 3
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Schleswig-Holstein Campus Kiel
    • Arnold-Heller-Str. 3
    • 24105  Kiel
    • Germany
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Status

  •   Recruiting planned
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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.