Trial document




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  DRKS00009986

Trial Description

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Title

Quantitative fMRI-imaging study of cerebral pathways during movement to music in patients with Parkinson’s Disease

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

It can be assumed that during movement to music (equalling dance, which in this case is executed as the rhythmical opening and closing of the fist as a simplified version thereof) alternative cerebral pathways are activated, improving motor skill in Parkinson’s patients.

One hypothesis implies a defect within the “internal pacemaker” in people with Parkinson’s which can be seen as so-called beta-oscillations in certain parts of the brain, such as the subthalamic nucleus and in parts of the globus pallidus, thereby impairing movement initiation. One can assume that dance improves motor skills, i.e. the initiation of movement, because the rhythm within the music functions as an external pacemaker.

The aim of this imaging study is to investigate if and how the activation of specific or alternative cerebral pathways correlates with improved motor skills.

The study implements the rhythmical opening and closing of the fist as a simplification of dance, as this movement is also evaluated during the L-DOPA-Test (UODRS part III). More complex movements such as dance would not be possible within the constraints of an MRI.

The activation of cerebral structures in people with Parkinson’s will be compared to matched, healthy controls.

Measurements will be conducted via functional magnetic resonance imaging (fMRI) at 1,5 Tesla using a standard coil.

The results will provide a basis for further research into Parkinson’s patients with Deep Brain Stimulation (DBS), as certain stimulation systems have recently received approval for MRI scans at 1,5 Tesla.

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Brief Summary in Scientific Language

The aim of this imaging study is to investigate whether and how the activation of specific or alternative cerebral pathways correlates with improved motor skills.
It can be assumed that during movement to music (equalling dance, which in this case is executed as the rhythmical opening and closing of the fist as a simplified version thereof) alternative cerebral pathways are activated, improving motor skill in Parkinson’s patients.

This activation of cerebral structures in people with Parkinson’s will be compared to matched, healthy controls.

Measurements will be conducted via fMRI at 1,5 Tesla using a standard coil.

The results will provide a basis for further research into Parkinson’s patients with Deep Brain Stimulation (DBS).

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Organizational Data

  •   DRKS00009986
  •   2016/04/05
  •   [---]*
  •   yes
  •   Approved
  •   524/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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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

  •   Parkinson's patients: opening and closing of the fist as a simplification of dance to 1.) rhythm, to 2.) music and 3.) in silence during fMRI imaging.
  •   Healthy controls: opening and closing of the fist as a simplification of dance to 1.) rhythm, to 2.) music and 3.) in silence during fMRI imaging.
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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


Assessment of difference in cerebral activity during movement to music, to rhythm and in silence in people with Parkinson's Disease. These differences in cerebral activity result in changes to the fMRI-signal which can be measured.

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Secondary Outcome



The differences in cerebral activity to rhythm, music and in silence correlate with the patient's movement to rhythm, music and in silence, respectively.
The amplitude and frequency of the movement (i.e. the opening and closing of the fist) is measured via a pressure sensor which the patient/ healthy control holds in their hand throughout the entire procedure.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/10/20
  •   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

Patients:
Patients over 18 with idiopathic Parkinson's Syndrome of the akinetic-rigid type.
Signed consent.


Healthy controls:
Neurologically healthy individuals matched for age, sex and dominant hand.
Signed consent.

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Exclusion Criteria

Patients:
(i) Contraindications for MRI scans (see also MRI information sheet), (ii) inappropriate physical conditions which prohibit a 30 - 45 minute MRI scan, (iii) brain pathologies such as history of stroke, severe cerbral microangiopathy, tumors, inflammation, (iv) pregnancy, (v) patients with Deep Brain Stimulation.

Healthy controls:
(i) Contraindications for MRI scans (see also MRI information sheet), (ii) inappropriate physical conditions which prohibit a 30 - 45 minute MRI scan, (iii) brain pathologies such as history of stroke, severe cerbral microangiopathy, tumors, inflammation, (iv) pregnancy, (v) Parkinson's Disease vi) Parkinsonoid symptoms.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Neuroradiologie
    • Mr.  Professor  Horst  Urbach 
    • Breisacher Strasse 64
    • 79106  Freiburg im Breisgau
    • Germany
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    • Klinik für Neuroradiologie
    • Mr.  Professor  Horst  Urbach 
    • Breisacher Strasse 64
    • 79106  Freiburg im Breisgau
    • Germany
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    • Klinik für Neurochirurgie
    • Mr.  Professor  Volker Arnd  Coenen 
    • Breisacher Strasse 64
    • 79106  Freiburg im Breisgau
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Neuroradiologie
    • Mr.  Prof. Dr.  Horst  Urbach 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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