Examination of the peripheral nervous system in Parkinson's patients with idiopathic Parkinson's syndrome (IPS) and atypical Parkinson's syndromes

Recruiting

Conditions: G20
G23.1
G23.2
G23.3
Parkinson disease
Progressive supranuclear ophthalmoplegia [Steele-Richardson-Olszewski]
Multiple system atrophy, parkinsonian type [MSA-P]
Multiple system atrophy, cerebellar type [MSA-C]

Registration Number: DRKS00020752

Lead Sponsor: St. Josef-Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

Male and female patients with idiopathic Parkinson's syndrome according to the UK Brain Bank criteria and the Movement Disorder Society PD criteria
- Male and female patients with atypical Parkinson's syndrome as defined by Progressive Supranuclear Palsy (PSP) according to the criteria of Höglinger 2017
- Male and female patients with atypical Parkinson's syndrome in terms of a multisystem atrophy (MSA) according to the criteria of Gilman 2008

Further inclusion criteria:
- Written informed consent based on Good Clinical Practice (GCP) and local legislation
- Age of majority
- Ability to give informed consent
- Legal capacity

Exclusion Criteria

- Lack of agreement with the protocol
- Drugs or alcohol addiction within 6 months before signing the consent form
- Stereotactic surgery in the history
- Electroconvulsive therapy in the last 180 days before screening
- Severe dementia based on a score of <10 in the Mini Mental State Examination (MMSE)
- Depression with suicidal thoughts (previous episodes of severe depression are not a criterion for exclusion
- Illiteracy or insufficient language skills

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical and electrophysiological detection of the presence of PNP in accordance with the criteria of the American Academy of Neurology for the definition of distal symmetrical polyneuropathy in clinical studies (England JD, Gronseth GS et al. 2005) and at least two of the following symptoms: (a) neuropathic symptoms, (b) decreased ankle reflexes, (c) decreased distal sensitivity and (d) distal muscle weakness or atrophy in patients with Parkinson's disease at baseline and follow-up after 1, 2, and 3 years.

Secondary Outcome Measures

Name	Time	Method
Determination of all secondary endpoints longitudinally repetitive:<br>- Determination of the stage in the modified Hoehn & Yahr scale and the point values in the Unified Parkinson Disease Rating Scale (MDS-UPDRS), the Unified Multiple System Atrophy Rating Scale (MDS-UMSARS), the PSP Rating Scale (PSPRS) and other motor and non-motor scores <br>- Electroneurographic parameters<br>- Neurological tilt table examination<br>- Clinical pathology<br>- Dermatohistopathology