G47.8 F06.7
Conditions
Interventions
Group 1: patients with idiopathic REM sleep behavior disorder (prodromal Parkinson's disease) with abnormalities in J-123-FP-CIT SPECT
Group 2: Patients with idiopathic REM sleep behavior disorder (pr
Sponsors
Klinik für Neurologie, Universitätsklinikum Jena
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Group 1: Patients of any gender with idiopathic REM sleep behavior disorder (prodromal Parkinson's disease) without parkinsonoid movement deficits and with reduced tracer uptake (z score = 18 years Group 2: Patients of any gender with idiopathic REM sleep behavior disorder (prodromal Parkinson's disease) without parkinsonoid movement deficits and with normal tracer uptake (z score >=-2) in J-123-FP-CIT SPECT, Age >= 18 years Group 3: Patients of any gender with amnestic Mild Cognitive Impairment (prodromal Alzheimer's disease), Age >= 18 years Group 4: Healthy control participants of any gender, adapted for age and gender, Age >= 18 years all groups: written consent after information
Exclusion criteria
Exclusion criteria: presence of a disease which could potentially impair the motor function or responsiveness, including the following: - neurological diseases: o history of stroke o history of cerebral haemorrhage o multiple sclerosis o history of meningitis or encephalitis o epilepsy o chronic headache or migraine (duration > 3 months, minimum of 15 days per month) o brain tumour o pronounced polyneuropathy with impairment of the upper extremities o neurodegenerative disease -->Parkinson's disease --> Alzheimer's disease or a different type of dementia - presentation of a presently treated, oncological disease - severe sight disorder that cannot be adjusted for by use of a visual aid - presentation of a cardiological disease with impaired left or right ventricular pump function (NYHA III-IV) - presentation of an orthopedic disease/injury/dysfunction that is ongoing or was present in the last 6 months, impairs the grip function and affects one or multiple of the following localisations: o upper extremity (hand, finger, wrist, elbow) o cervical spine o thoracis spine - centrally acting medication that possibly impairs the motor function or responsiveness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes are the results of the falling stick test and are measured during the study visit: -distance (in centimeters) the stick drops until it is touched/caught/stopped from falling -grip force when the stick is caught/stopped from falling. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes and covariates are mainly measured during the study visit. Only the CERAD-plus battery is done before to exclude patients with dementia. Secondary Outcomes: motoric function: - UPDRS motor scale - Timed Up and Go Test (duration in seconds) - Grooved Pegboard (duration in seconds) - Alternate Tap Test (count in time period) neurocognition: - CERAD-plus battery incl. MMSE - Montreal Cognitive Assessment (MoCA) - Whole Report paradigm (with cueing) based on the theory of visual attention (parameters of visual attention) Covariates: sociodemographic data: - age (years) - gender (male/female/other) - handedness (left-/right-dominant) - weight (kg) - height (cm) - level of motoric activity (German PAQ-50+) - school education - vocational education - nationality - migration status - country of origin - years since disease onset (only for Groups 1 & 2) - level of intelligence (MWT-B) objective sleep quality: - sleep efficiency - sleep onset latency - percentaged distribution of sleep stages - arousal index - muscle tone (tonic/phasic activity, REM sleep atonia index, phasic EMG density, short movement index, long movement index) - RBD severity scale (only for Group 1) subjective sleep quality: - Insomnia severity index - Pittsburgh sleep quality index - Epworth sleepiness scale mental comorbidities: - hospital anxiety and depression scale | — |
Countries
Germany
Contacts
Public ContactSolveig Menrad
Klinik für Neurologie, Universitätsklinikum Jena
Outcome results
None listed