Trial document




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  DRKS00008765

Trial Description

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Title

Dopaminergic and cholinergic modulation of oculomotor control during saccades

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In this basic science study we investigate the role of the neurotransmitters Dopamine and Acetylcholine in the oculomotor control of healthy participants. We manipulate the level of Dopamine and Acetylcholine using drugs from daily clinical routine and apply placebo as a control condition. After administration of a single dose of a substance, participants perform a series of behavioral tasks on a computer. We measure their eye movements and use mathematical models to describe them. We then investigate the role of Dopamine (or Acetylcholine) by probing which parameters of the mathematical model capture effects of the different neurotransmitter systems.

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Brief Summary in Scientific Language

Currently, it is not known how dopamine and acethylcholine modulate eye movements and corollary discharges during saccades. We plan to investigate the role of these two neuromodulators during eye movements while healthy subjects perform eye movement tasks. For this purpose, we plan to use approved drugs of common clinical use and minimal side effects in a placebo-controlled single dose pharmacological challenge with cross-over design.

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Organizational Data

  •   DRKS00008765
  •   2015/06/11
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  •   yes
  •   Approved
  •   KEK-ZH-Nr. 2014-0246, Kantonale Ethikkommission des Kantons Zürich, Zürich, Schweiz
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Secondary IDs

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Health Condition or Problem studied

  •   Healthy participants
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Interventions/Observational Groups

  •   Healthy particpants, pharmacological challenge (single dose) with Madopar®250 mg vs. placebo (lactose). Followed by eye movement tasks. Modelling of data with mathematical models.
  •   Healthy particpants, pharmacological challenge (single dose) with Reminyl® 8mg vs. placebo (lactose). Followed by eye movement tasks. Modelling of data with mathematical models.
  •   Healthy particpants, no substance. Eye movement tasks. Modelling of data with mathematical models.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo, Control group receives no treatment
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   No
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Primary Outcome

Goal of the study: Understanding how neuromodulators modulate the control of saccadic eye movements. Modelparameters of eye movement models will be compared statistically between drug and placebo conditions.

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Secondary Outcome

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Countries of Recruitment

  •   Switzerland
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2015/06/30
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   40   Years
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Additional Inclusion Criteria

• Age: ≥18 and ≤40 years
• Male sex
• European ancestry
• Written informed consent
• Consent to adhere to the study protocol
• Ability to adhere to the study protocol

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Exclusion Criteria

General:

• Serious past or present brain disease, brain injury or brain surgery
• Any neurological or psychiatric disorders (past or present)
• Current psychoactive medication
• Daily nicotin use
• Daily alcohol use > 2 units per day on average (1 unit = 3 dl beer = 1 dl wine)
• Current use of recreational drugs
• History of drug abuse
• Any current severe medical condition
Additional exclusion criteria for the pharmacological study branches:
• Tachy- or bradycardia (normal range 55-100 bpm), cardiac arrhythmia and/or QTc-time >430 ms
• History of severe kidney or liver disorder
• Prostate or bladder disorder
• Glaucoma
• Asthma or other obstructive respiratory disease
• Current medication known to interact with levodopa, benserazide, or galantamine
• Allergy to lactose, levodopa, benserazide, or galantamine

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Addresses

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    • Translational Neuromodeling Unit, Institut für Biomedizinische Technik, Universität Zürich und ETH Zürich
    • Mr.  Prof.  Klaas Enno  Stephan 
    • Wilfriedstrasse 6
    • 8032  Zürich
    • Switzerland
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    • Translational Neuromodeling Unit, Institut für Biomedizinische Technik, Universität Zürich und ETH Zurich
    • Mr.  Dr  Jakob  Heinzle 
    • Wilfriedstrasse 6
    • 8032  Zürich
    • Switzerland
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    • Translational Neuromodeling Unit, Institut für Biomedizinische Technik, Universität Zürich und ETH Zurich
    • Mr.  Dr  Jakob  Heinzle 
    • Wilfriedstrasse 6
    • 8032  Zürich
    • Switzerland
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Sources of Monetary or Material Support

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    • Universität Zürich
    • Rämistrasse 71
    • 8006  Zürich
    • Switzerland
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Status

  •   Recruiting complete, follow-up complete
  •   2017/06/30
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Trial Publications, Results and other Documents

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