Digital recording and longitudinal observation of the holistic quality of life of Parkinson patients and their relatives

Not yet recruiting

Conditions: G20
Parkinson disease

Registration Number: DRKS00023598

Lead Sponsor: niversitätsklinikum Gießen und MarburgStandort Marburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 1000

Inclusion Criteria

Patients suffering from a clinical diagnosis of iPD according
to the recent clinical diagnostic criteria (MDS criteria)

iPD-stages of I – IV according to the Hoehn & Yahr scale
(in the OFF state, i.e., without medication)

Patients aged between between 30 and 100 years

Patients with the ability to provide informed consent. In
cases where participants lose their capacity to consent at
follow-up visits (e.g., due to dementia, etc.), this participant
will only be allowed to continue if a legal representative
(proxy, guardian) provides informed consent to further par-
ticipation on behalf of the participant. In this case, the
legal representatives will be provided with a separate consent form

Exclusion Criteria

Patients suffering from a clinical diagnosis of atypical Parkin-
son’s syndrome in a first instance. Patients enrolled who
were later characterized as atypical Parkinson syndroms will
not be excluded.

iPD-stages of V according to the Hoehn & Yahr scale (in
the OFF stage, i.e. without medication)

The use of magnetic fields in the MRI examination excludes
the participation of persons who have electrical devices (e.g.,
cardiac pacemakers, medication pumps, etc.) or metal parts
(e.g., screws after bone fracture) in or on their bodies

Women who are pregnant will not receive MRI.

Subjects who do not want to be informed about possible
incidental findings are also not allowed to participate in the imaging part of the study

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Parkinson's disease patients holistic quality of life - measurements take place every half year in the form of a questionnaire

Secondary Outcome Measures

Name	Time	Method
Symptom severity, affective symptoms, cognitive decline, sleep quality at six-monthly assessments. In addition, structural changes in the brain will be assessed by cranial imaging and metabolic changes will be assessed in blood, saliva, urine and stool samples. These changes are recorded through annual presentations and sample collection or measurements. In addition, quality of life, coping, resilience and family burden are assessed. Measurements are also taken every six months using questionnaires.