Trial document




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  DRKS00003290

Trial Description

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Title

Morphometric correlates and predictors of impaired gait and balance in Parkinson’s Disease-a pilot study

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Trial Acronym

KLI82-B00

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Based on the predominant motor phenotype, Parkinson’s Disease (PD) is often sub-classified into tremor-dominant and akineto-rigid subtypes. More recently, a motor pattern dominated by postural instability and gait disorder has attracted clinical interest, because of its association with more rapid disease progression and faster rate of cognitive decline. This is believed to result from more widespread degeneration within the brain, however the underlying neuropathologic patterns producing gait and balance problems in Parkinson's Disease are yet not fully understood.
In this project high-resolution MRI, with a field strenght of 3.0 Tesla, will be employed to assess cerebral changes occurring in patients with PD compared to healthy controls, to discriminate patients with PD from healthy controls, to assess changes occurring in patients with and without gait or balance disturbances and to determine progression of atrophy patterns in the brain.
For this purpose, we will prospectively study 80 patients with PD and a group of 20 healthy controls matched for gender and age. All participants will undergo a detailed standardised clinical assessment including several well established measures on gait and balance function as well as a standardised MRI protocol. Over a follow-up period of at least 12 months the clinical and MRI protocols will be repeated.

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Brief Summary in Scientific Language

Based on the predominant motor phenotype, Parkinson’s Disease (PD) is often sub-classified into tremor-dominant and akineto-rigid subtypes. More recently, a motor pattern dominated by postural instability and gait disorder (PIGD subtype) has attracted clinical interest, because of its association with more rapid disease progression and faster rate of cognitive decline. This is believed to result from more widespread brainstem and cortical/subcortical degeneration involving the substantia nigra, extranigral nuclei like the locus coeruleus and pedunculopontine nucleus as well as striato-frontal connections. However, the underlying patterns of neurodegeneration producing gait and balance problems in PD are not fully understood.
In this project, multimodal MRI sensitive to complementary tissue characteristics, i.e. volume atrophy via whole-brain T1-weighted MRI, iron deposition via MR relaxometry and microstructural damage via DTI will be employed (i) to assess changes occurring in patients with PD compared to healthy controls, (ii) to discriminate patients with PD from healthy controls, (iii) to assess changes occurring in patients with the PIGD subtype of PD compared to PD patients presenting with a non-PIGD subtype and (iv) to determine progression of multimodal MR-indices.
Another approach for elucidating the problem discussed above is the comparison of neuronal connectivity. In the last ten years, a new insight to the recording of blood oxygen dependent (BOLD) signal has been grown. During resting state of volunteers, the spontaneous oscillation of BOLD signals, suspected to reflect neuronal activity, can be acquired during an fMRI session without paradigm. The spontaneous oscillation reaches the same level in areas, which are supposed to be closely connected. Therefore, the evaluation of different level of spontaneous depicts neuronal networks.
For this purpose, we will prospectively study 80 patients with PD and a group of 20 healthy controls matched for gender and age. All participants will undergo a detailed standardised clinical assessment including several well established measures on gait and balance function as well as a standardised MRI protocol including coronal T1-weighted MPRAGE, transversal turbospinecho PD/T2-weighted sequence, coronal TIRM sequence with dark fluid preparation, transversal diffusion-weighted echoplanar imaging (EPI) sequence with 12 diffusion-sensitized gradient directions (for DTI), transversal multi-echo gradient-echo sequence (for MR relaxometry) and contrast-enhanced MRI (for exclusion of cerebral masses). The so-called resting state fMRI comprises a T2*-weighted echoplanar imaging (EPI) sequence, which covers the whole brain and is repeatedly performed over a period of 8 minutes. Over a follow-up period of at least 12 months the clinical and MRI protocols will be repeated.

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Organizational Data

  •   DRKS00003290
  •   2011/10/05
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  •   yes
  •   Approved
  •   AN4475 304 / 4.22 , Ethikkommission der Medizinischen Universität Innsbruck
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Secondary IDs

  •   U1111-1124-8649 
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Health Condition or Problem studied

  •   G20 -  Parkinson's disease
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   Patients with Parkinson's disease without gait- and/or balancedisturbances. An MRI examination with 3.0 Tesla will be done in each participant. Furthermore a clinical examination of gait, balance and cognition including different test batteries will be performed (Berg Balance Scale, Functional Gait Assement, BESTest, Time Walking Test, Timed „Up & GO WITH DUAL TASK “ Test, Stops Walking When Talking Test, Tinetti Balance – Score, Tinetti Gait – Score, FOG, MMSE- Score, Panda – Score, MOCA – Score, PDQ39 – Score).
  •   Patients with Parkinson's disease with gait- and/or balancedisturbances. An MRI examination with 3.0 Tesla will be done in each participant. Furthermore a clinical examination of gait, balance and cognition including different test batteries will be performed (Berg Balance Scale, Functional Gait Assement, BESTest, Time Walking Test, Timed „Up & GO WITH DUAL TASK “ Test, Stops Walking When Talking Test, Tinetti Balance – Score, Tinetti Gait – Score, FOG, MMSE- Score, Panda – Score, MOCA – Score, PDQ39 – Score).
  •   Healthy controls. An MRI examination with 3.0 Tesla will be done in each participant. Furthermore a clinical examination of gait, balance and cognition including different test batteries will be performed (Berg Balance Scale, Functional Gait Assement, BESTest, Time Walking Test, Timed „Up & GO WITH DUAL TASK “ Test, Stops Walking When Talking Test, Tinetti Balance – Score, Tinetti Gait – Score, FOG, MMSE- Score, Panda – Score, MOCA – Score, PDQ39 – Score).
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Characteristics

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

Evaluation of morphometric correlates and predictors of impaired gait and balance in Parkinson’s Disease in 3.0 Tela MRI.

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Secondary Outcome

The aims of this study are (i) to assess changes occurring in patients with PD compared to healthy controls, (ii) to discriminate patients with PD from healthy controls and (iii) to assess changes occurring in patients with the PIGD subtype of PD compared to PD patients presenting with a non-PIGD subtype (iv) to determine progression of morphometric MR-indices using multimodal MRI sensitive to complementary tissue characteristics.

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Countries of Recruitment

  •   Austria
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2011/11/01
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   85   Years
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Additional Inclusion Criteria

A) Inclusion criteria patients: 1) the subject is aged between 40 and 85 years; 2) clinical diagnosis of PD obtained by a neurologist according to published clinical diagnostic criteria; 3) the patient has the ability to communicate well with the investigator and comply with the requirements of the study; 4) written informed consent is obtained.
B) Inclusion criteria healthy controls: 1) the subject is aged between 40 and 85 years; 2) written informed consent is obtained. 3) The subject has the ability to communicate well with the investigator and comply with the requirements of the entire study

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Exclusion Criteria

BA Exclusion criteria patients: 1) History of other neurological or psychiatric disorders or conditions; 2) The subject has a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM IV). 3) the subject is pregnant. 4) the subject is unsuitable for an MRI study (e.g. Pacemakers; medical or bio-stimulation implants which are contraindicated for MRI scans and which may include vagus nerve stimulators, implantable cardioverter-defibrillators, loop recorders, insulin pumps, cochlear implants)
B) Exclusion criteria healthy controls: 1) History of neurological or psychiatric disorders or conditions; 2) The subject has a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Edition (DSM IV). 3) the subject is pregnant. 4) the subject is unsuitable for an MRI study (e.g. Pacemakers; medical or bio-stimulation implants which are contraindicated for MRI scans and which may include vagus nerve stimulators, implantable cardioverter-defibrillators, loop recorders, insulin pumps, cochlear implants).

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Addresses

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    • Medizinische Universität Innsbruck Universitätsklinik für Neurologie
    • Mr.  ao. Univ. Prof. Dr.  Klaus  Seppi 
    • Anichstrasse 35
    • 6020   Innsbruck
    • Austria
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    •   004351250425812
    •   004351250425819
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    • Medizinische Universität Innsbruck Universitätsklinik für Neurologie
    • Ms.  Dr.  Anna  Hussl 
    • Anichstrasse 35
    • 6020  Innsbruck
    • Austria
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    • Universitätsklinik für Radiologie I
    • ao. Univ. Prof. Dr.  Michael  Schocke 
    • Anischstrasse 35
    • 6020  Innsbruck
    • Austria
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    • Universitätsklinik für Neurologie
    • o. Univ. Prof. Dr.   Werner  Poewe 
    • Anichstrasse 35
    • 6020  Innsbruck
    • Austria
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    • Universitätsklinik für Radiologie I
    • OÄ Dr.  Regina   Esterhammer 
    • Anischstrasse 35
    • 6020   Innsbruck
    • Austria
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    • Universitätsklinik für Neurologie
    • ao. Univ. Prof. Dr.  Christoph  Scherfler 
    • Anichstrasse 35
    • 6020  Innsbruck
    • Austria
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    • Medizinische Universität Innsbruck Universitätsklinik für Neurologie
    • Ms.  Dr.  Anna  Hussl 
    • Anichstrasse 35
    • 6020  Innsbruck
    • Austria
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Sources of Monetary or Material Support

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    • FWF - Der Wissenschaftsfonds Haus der Forschung
    • Sensengasse 1
    • 1090  Wien
    • Austria
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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