Trial document




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  DRKS00005033

Trial Description

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Title

The assessment of pilomotor function using QPART (quantitative pilomotor axon-reflex test) in patients with diabetic neuropathy and patients with Parkinson's disease

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Trial Acronym

QPART 001

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URL of the Trial

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Brief Summary in Lay Language

This study includes the assessment of the abilty of the skin to produce goose bumps. The ability to produce goose bumps is controlled by the autonomic nervous system which is the part of the nervous system that cannot be controlled by the mind. In order to adequately treat autonomic nerve fiber diseaese due to diebetes or Parkinson's disease (PD) early detection of this diesase is necessary. To date, there are few techniques to assess autonomic nerve function. This study aims to investigate the capability of a novel autonomic nerve fiber function test (QPART) to assess pilomotor (goose bumps mediating) nerve fiber function. The QPART technique uses iontophoretic application (application through weak electric current) of phenylephrine to induce local goose bumps on the foreram. Phenylephrine is an adrenergic nerve fiber stimulating agent. The response will be asssessed through silicone impressions. The QPART technique will be tested in diabetic patients, in PD patients, and in healthy control subjects.

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Brief Summary in Scientific Language

Autonomic neuropathy is a prevalent disorder in patients with Parkinson's disease and patients with diabetes and is linked to increased cardiovascular mortality and reduced life quality. To date, there are few techniques available to assess autonomic neuropathy clinically. These techniques include sudomotor and vasomotor function assessment. However, vasomotor and sudomotor techniques are technically demanding and therefore not widely used in clinical neuropathy assessment. The objective of this pilot study is to assess autonomic nerve function in patients with Parkinson's disease and patients with diabetes using the Quantitative Pilomotor Axon-Reflex Test (QPART), a novel and easily performed technique to assess pilomotor nerve fiber function. The QPART technique measures phenylephrine induced noradrenergic piloerection utilizing silicone indentations of piloarrector muscles. (Siepmann et al. Archives of Neurology 2012)This study aims to assess pilomotor function in patients with Parkinson's disease and patients with diabetic neuropathy and to compare the results obtained through QPART with standard measures of vasomotor and sudomotor function. We hypothesize that QPART is a valid and easy to use technique to assess small autonomic neuropathy.

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Organizational Data

  •   DRKS00005033
  •   2013/06/19
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  •   yes
  •   Approved
  •   EK 12012013, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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Secondary IDs

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Health Condition or Problem studied

  •   Healthy subjects
  •   G20 -  Parkinson disease
  •   G63.2 -  Diabetic polyneuropathy
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Interventions/Observational Groups

  •   In study arm 1, 24 patients with diabetic neuropathy will undergo the QPART method on both volar forearms. (Siepmann et al. Archives of Neurology 2012).
    Comparative standard autonomic measures (Sympathetic Skin Response, Laser Doppler Flowmetry) will be performed once on the same testing day. (Freeman at al. Lancet 2005)
  •   In study arm 2, 24 patients with Parkinson's disease will undergo the QPART method on both volar forearms. (Siepmann et al. Archives of Neurology 2012).
    Comparative standard autonomic measures (Sympathetic Skin Response, Laser Doppler Flowmetry) will be performed once on the same testing day. (Freeman at al. Lancet 2005)
  •   In study arm 3, 24 healthy subjects will undergo the QPART method on both volar forearms. (Siepmann et al. Archives of Neurology 2012). Comparative standard autonomic measures (Sympathetic Skin Response, Laser Doppler Flowmetry) will be performed once on the same testing day. (Freeman at al. Lancet 2005)
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Double or multiple blind
  •   assessor, data analyst
  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Number of hair follicle silicone indentations - analysis through counting of the indentation in silicon scans- analysis on the day of measurement

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Secondary Outcome

Volume and area spread of hair follicle silicone indentations - analysis through digital image analysis of the indentations in silicon scans- analysis on the day of measurement

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2013/08/15
  •   72
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Male and female patiens with diabetic neuropathy ages 18-75 years will be inculded following full written informed consent. Furthermore male and female healthy control subjects as wella as male and female patiens with Parkinson's disease ages 18-75 years will be inculded following full written informed consent. Each diagnosis (Parkinsion's disease or diabetic neuropathy) has to be cproven previously.

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Exclusion Criteria

Patient arms:
- intake of beta-blockers within 14 days previous to beginning of the study
- intake of antidepressants within 3 months previous to beginning of the study
- dermatologic comorbidities affecting the testing sites
- known allergy to phenylephrine
- consumption of more than 10 cigarettes per day
- consumption of one alcoholic beverage per day
- consumption of any nicotine, caffeine or alcohol at the testing day
Control arm:
-any acute of chronic disease
-chronic intake of medication
- consumption of more than 10 cigarettes per day
- consumption of one alcoholic beverage per day
- consumption of any nicotine, caffeine or alcohol at the testing day

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Addresses

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    • Institut für Klinische Pharmakologie Medizinische Fakultät Carl Gustav Carus Technische Universität Dresden
    • Mr.  Prof. Dr. Dr.  Wilhelm  Kirch 
    • Fiedlerstraße 27
    • 01307  Dresden
    • Germany
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    • Klinik und Poliklinik für Neurologie Universitätsklinikum Carl Gustav Carus
    • Mr.  Dr. med.   Timo   Siepmann  
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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    • Klinik und Poliklinik für Neurologie Universitätsklinikum Carl Gustav Carus
    • Mr.  Dr. med.  Timo   Siepmann 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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Sources of Monetary or Material Support

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    • Prothena Biosciences Inc,
    • 650 Gateway Boulevard
    • 94080  South San Francisco
    • United States
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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