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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00020752

Enrollment

150

Registered

2020-02-07

Start date

2018-10-16

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G20 G23.1 G23.2 G23.3

Interventions

Group 1: The following values are determined for patients with idiopathic Parkinson's syndrome: - Determination of the stage in the modified scale according to Hoehn and Yahr and further motor and no

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
Determination of all secondary endpoints longitudinally repetitive: - 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 - Electroneurographic parameters - Neurological tilt table examination - Clinical pathology - Dermatohistopathology	—

Measure

Time frame

Determination of all secondary endpoints longitudinally repetitive: - 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 - Electroneurographic parameters - Neurological tilt table examination - Clinical pathology - Dermatohistopathology

—

Countries

Germany

Contacts

Public ContactTeresa Kleinz

St. Josef-Hospital

Teresa.Kleinz@rub.de0234-5092475

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 9, 2026