G20.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Klinik für Neurologie, Universitätsklinikum Gießen-Marburg, Standort Marburg