Trial document




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  DRKS00015807

Trial Description

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Title

Improving self-awareness for motor symptoms in patients with Parkinson's Disease by using Mindfulness

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Trial Acronym

IPSUM

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Recent scientific research suggests that patients with Parkinson’s Disease are affected by an impaired self-awareness for motor symptoms. Consequences of this impaired self-awareness are lower therapy adherence, higher patient mortality and caregiver burden. It is therefore of high relevance.
This study is conducted to evaluate the effectiveness of IPSUM, a newly developed, body oriented mindfulness training to improve self-awareness of motor symptoms in patients with Parkinson’s Disease. During the training participants learn to know the concept of mindfulness and train their awareness for thoughts, feelings and body sensations in many practical exercises.
Eligible patients are randomly assigned to a training or a control group. The training group takes part in the training as well as three scientic measurements: before, directly after and eight weeks after participation. The control group also takes part in the same three measurements, but not in the training. After completing the third and last measurement patients of the control group get the chance to also participate in the training. During the three measurements every patient shall complete questionnaires about their emotional well-being and tasks for testing several functions of thinking. They also are examined by a doctor and are sought to answer some questions regarding their motor impairment and cognitive performance. Some patients are asked to take part in a functional magnetic resonance imaging (fMRI). After completing the training there is the option to take part in an interview about possible changes during the last weeks.
We expect this new mindfulness intervention, designed for the specific needs of patients with Parkinson’s Disease, to improve their self-awareness and thus enhancing their quality of life on many levels.

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Brief Summary in Scientific Language

Anosognosia for motor impairment in non-demented patients with Parkinson’s Disease (PD) was rarely considered in the past. More recent research has suggested that impaired self-awareness of motor symptoms (ISAm) exists in non-demented patients. An impaired self-awareness is associated with lower adherence, as well as higher patient mortality and caregiver burden and has therefore a high clinical relevance.
This study investigates the improvement of ISAm using IPSUM, a newly developed, body-oriented mindfulness intervention. In order to evaluate the effectiveness of this eight week long intervention, cognitive, emotional, behavioral and structural neurological changes are evaluated.
Non-demented, non-depressed patients with idiopathic PD, who show signs of ISAm, are randomized to an intervention or a waitlist-control group. Applying an adaptive Pre-Post-Design, patients are measured for their self-awareness of motor symptoms by using a recently validated scale for impaired motor-awareness (see Maier et al., 2015) at three points in time: before, directly after, and eight weeks after participating in the intervention. The effectiveness of the intervention is determined by significant differences of ISAm between both groups, whereas the intervention group’s awareness is expected to be higher (after their participation). Also, neuropsychological and self-report measures are applied to evaluate cognitive and affective changes. Performance monitoring for cognitive performance is used as an indicator for impaired self-awareness of cognitive symptoms. Some patients undergo a resting-state fMRI scan before and directly after the intervention. Additionally, qualitative data for changes of body and self-awareness is collected in a semi-structured interview during post-measurement. A maximum of 180 patients will be included. Because of an adaptive group sequential design, several interim analyses are carried out over time and the trial might be stopped beforehand (efficacy stop).
The intervention manual has been created. Two implementations for feasibility testing are planned. If necessary some changes to the manual will be applied. As the main outcome, we expect an improvement of quantitative measured ISAm over time in the intervention but not the control group.
We expect this new mindfulness intervention, designed for the specific needs of PD patients, to improve ISAm and thus enhancing their quality of life on many levels.

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Organizational Data

  •   DRKS00015807
  •   2018/10/29
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  •   yes
  •   Approved
  •   119/18, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

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Health Condition or Problem studied

  •   G20.1 -  [generalization G20: Parkinson disease]
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Interventions/Observational Groups

  •   The intervention group takes part in three measurements at different points in time. Between the first two measurement they participate in the intervention. During the eight week long intervention, which is developed for the specific needs of patients with Parkinson’s Disease, the patients‘ awareness for themselves and their motoric symptoms shall be improved. To achieve that goal the participants learn about the concept of mindfulness and also train their awareness for their own thoughts, feelings and body sensations in many practical exercises.
    The following measurements take place at three points in time: T1 = before the intervention, T2 = directly after the intervention, T3 = eight weeks after completing the intervention (follow-up)

    1) ISAm-Scale: Quantitative evaluation of self-awareness for motor Symptoms.

    2) Measurement of cognitive Performance with the following neuropsychological tests:
    - Verbaler Lern- und Merkfähigkeitstest (VLMT): verbal memory
    - Regensburger Wortflüssigkeitstest (RWT): word fluency
    - Farb-Wort-Interferenztest nach J.R. Stroop (FWIT): executive functioning
    - Testbatterie zur Aufmerksamkeitsprüfung; Subtest: Permanent Attention) (TAP): permanent attention
    - Extended Complex Figure Test - motor independent (ECFT-MI): visuo-spatial abilities

    2) Measurement of congruence between real cognitive performance (according to norm values) and estimated performance (rated by the patient).

    3) Measurement of emotional well-being:
    - Beck Depression Inventory (BDI-II): Depression
    - Perceived Stress Questionnaire (PSQ): Experienced stress
    - State-Trait Angst Inventar (STAI): Perceived Fear
    - Parkinson's Disease Questionnaire (PDQ-39): Quality of Life
    - Dysexecutive Questionnaire (DEX): Subjective Cognitive Impairment in everyday life
    - Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease (QUIP): Impulsivity
    - Apathy Evaluation Scale (AES): Apathy
    - Parkinson's Disease Sleep Scale-2 (PDSS-2) Sleeping Problems
    - Five Facet Mindfulness Questionnaire - german version (FFMQ-D): Mindfulness

    - Some patients undergo a structural fMRI scan (at T1 and T2)
    - Voluntary participation in an interview about possible changes reagarding body- and self-awareness (at T2 and T3)

  •   The control group takes part in all measurements at all three points in time, as well, and will complete the same tasks as the intervention group (except the voluntary interview). However, the control group will not participate in the intervention between T1 and T2. Members of the control group get the chance to participate in the intervention after completing the third and final measurement.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, assessor
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

ISAm-Scale: Quantitative evaluation of self-awareness for motor Symptoms. Though measured at all three Points in time, the second measurement (directly after participation in the intervention) is used as evaluation for primary Outcome.


Patients are shown several video clips with various movements (e.g. pronation/ supination of the hand, standing up from a chair, walk a short way, etc.) and are asked to repeat the movement themselves. After that the Patients rate their performance: was the movement impaired or not? The whole procedure is recorded by video. Later, blinded raters will evaluate the movements as well. If the Patient does not see any impairment, although the rater does, an impaired self-awareness is indicated. The number of discrepancies reflects the degree of impaired self-awareness of motor symptoms. Depending on the movement the global score can be divided into sub-scores for impaired self-awareness for hypomotoric symptoms (e.g. bradykinesia) and hypermotoric symptoms (levodopa induced diskenisias).

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Secondary Outcome

The following changes regarding the secondary outcome are evaluated between time point 1 (before the intervention) and time point 2 (directly after the intervention).

1) Improvement of cognitive Performance in one of the following neuropsychological Tests:

- Verbaler Lern- und Merkfähigkeitstest (VLMT): verbal memory
- Regensburger Wortflüssigkeitstest (RWT): word fluency
- Farb-Wort-Interferenztest nach J.R. Stroop (FWIT): executive functioning
- Testbatterie zur Aufmerksamkeitsprüfung; Subtest: Permanent Attention) (TAP): permanent attention
- Extended Complex Figure Test - motor independent (ECFT-MI): visuo-spatial abilities


2) Improvement of congruence between real cognitive performance (according to norm values) and estimated performance (rated by the patient).


3) Improvement of emotional well-being:
- Beck Depression Inventory (BDI-II): Depression
- Perceived Stress Questionnaire (PSQ): Experienced stress
- State-Trait Angst Inventar (STAI): Perceived Fear
- Parkinson's Disease Questionnaire (PDQ-39): Quality of Life
- Dysexecutive Questionnaire (DEX): Subjective Cognitive Impairment in everyday life
- Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease (QUIP): Impulsivity
- Apathy Evaluation Scale (AES): Apathy
- Parkinson's Disease Sleep Scale-2 (PDSS-2) Sleeping Problems
- Five Facet Mindfulness Questionnaire - german version (FFMQ-D): Mindfulness

4) Structural differences during both resting-state fMRI in the insular and cingular cortices

Also, qualitative reported changes regarding body and self-awareness (during the interviews at T2: directly after the intervention and T3: eight weeks after the intervention) are used as secondary outcome.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/01/09
  •   180
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

• Male and female patients with clinical diagnoses of idiopathic Parkinson's Disease (IPD) following MDS-criteria
• IPD-Stadium II – IV following Hoehn & Yahr (in OFF-State)
• IPD-Therapy: No changes during the last 14 days
• Patients between 45 and 85 years old
• Patients must be able to consent and subscribe a declaration of consent
• Patients must show signs of impaired self-awareness of motor Symptoms during screening procedure
• Patients must speak the german language fluently

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Exclusion Criteria

• Patients who suffer from another cognition impairing disease (such as vascular incidents, tumor, etc.)
• Patients with severe Depression (BDI-II > 18 points) and/or Dementia (PANDA < 15 points)
• expected incompliance regarding study participation
• severe motor complications (unforeseeable ON-OFF-states, severe dyskinesias, severes OFF-Dystonia)
• increased risk of falling
• current psychotic symptoms
• state after recent stroke, intracranial Operation, cerebral tumor
• state after lung embolism, myocardial infarction, endocarditis during the last 3 months
• regular (at least once per week) practice of yoga or Meditation during the last 3 months
• Optional: MRI-Contraindication: The use of magnetic fields during MRI measurement disqualifies people with medical electrical Equipment (e.g. Pacemaker, medication pump, etc.) or metal parts (e.g. bolts after bone fracture) in or at the body. Pregnant women are also disqualified. Patients who do not want to be informed of possible incidental findings cannot participate as well.

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Addresses

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    • Philipps-Universität Marburg
    • 35032  Marburg
    • Germany
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    • Klinik für Neurologie, Universitätsklinikum Gießen-Marburg, Standort Marburg
    • Mr.  Timo  Buchwitz 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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    • Klinik für Neurologie, Universitätsklinikum Gießen-Marburg, Standort Marburg
    • Mr.  Timo  Buchwitz 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Philipps-Universität Marburg
    • 35032  Marburg
    • Germany
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    • Deutsche Parkinson Vereinigung e.V. - Bundesverband -
    • Moselstraße 31
    • 41464  Neuss
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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