Training Cognition in patients with advanced Parkinson's Disease (TrainParC-Advanced) - Feasibility, Effects and Prediction of Responsiveness of a digital cognitive training

Not Applicable

Recruiting

Conditions: G20
Parkinson disease

Registration Number: DRKS00028876

Lead Sponsor: niversität zu Köln

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 140

Inclusion Criteria

1. Patients with IPD according to the UK Brain Bank criteria (Gibb & Lees, 1988).
2. Advanced stage disease, defined as IPD patients who meet = 1 of the 5-2-1 criteria: 5 intakes of levodopa tablets per day and/or 2 hours of OFF time per day and/or 1 hour of troublesome dyskinesia per day (Antonini et al., 2018; Santos-García et al., 2020) or receive pump therapy
3. Patients who are cognitively unimpaired or have only suspected MCI (MoCA > 21 points; Dalrymple-Alford et al., 2010)
4. Patients who have stable medication within the last 4 weeks before training and between baseline and posttest
5. Age: 18 years and older; all genders
6. German as native language or sufficiently good knowledge of German
7. Access to a computer, laptop or tablet with internet access

Exclusion Criteria

1. Dementia according to level 1 diagnostics (MoCA < 21 points; Dalrymple-Alford et al., 2010)
2. Major depression (BDI-II = 29 points; Beck et al., 1996).
3. Epilepsy and other diseases with seizure-like manifestations and/or disorders of consciousness (ICD-10 G40)
4. Other neurological or psychiatric illness; acute life-threatening illness (self-report in medical history and physician's letters).

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global cognition (MoCA; baseline, posttest + follow-up; measurement procedure administered by a blinded test administrator)

Secondary Outcome Measures

Name	Time	Method
Baseline only: cognitive reserve (LEQ; questionnaire)<br><br>All of the following endpoints will be conducted at baseline, posttest, and 3-month follow-up by a blinded test administrator: <br>1. neuropsychological measurement procedures to measure specific cognitive functions and fluid intelligence: CERAD plus test battery, BTA, WMS-R forward and backward number span, Benton Judgement of Line Orientation Form H (short version), LPS subtest 4 and subtest 9, ACL auditory language comprehension subtest.<br>2. measurement of motor skills: UPDRS-III, Hoehn & Yahr, Timed Up and Go<br>3. questionnaires (self-report): Quality of Life (PDQ-39), Subjective Cognitive Impairment (SCI), Depressive Symptomatology (BDI-II), Fatigue (FSMC), Apathy (AES), Self-Efficacy (SWE), Progression Anxiety (PA-F-KF), Activities of Daily Living (B-ADL), Non-Motor Symptomatology (NMSQ), Fear of Falling (FES), Freezing of Gait (FOG-Q), Sleep Quality (PDSS)