Objective Assessment of Behavioural Disorders in PD

Study Overview
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Brief Summary
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The aim of this project is to measure behavioural disorders in Parkinson's disease (PD) patients in a more objective way, in order to facilitate the detection of those symptoms and improve the treatment of non-motor symptoms in Parkinson's disease.

Detailed Description
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Apathy and impulse control disorders (ICDs) are frequent non-motor symptoms of PD and negatively affect the quality of life of patients. Although healthcare professionals have begun to understand the extent of the problem faced by those suffering apathy or ICDs, accurate diagnosis is still difficult, as behavioural symptoms are often multidimensional, develop gradually over the course of months and clinical staff have to rely on the self-report of the patient or the report of a family member to assess them. To overcome this issue, the investigators aim to use information and communication technologies to measure apathy and hyperdopaminergic behaviours in PD patients in an objective way, with the ultimate goal of improving the management of PD patients. To do so, the investigators will use three computer-based tasks that measure effort-based decision making, reward processing and emotion processing in PD patients, and assess motor, cognitive and neuropsychiatric symptoms in parallel with scales and tests. In some select patients, motor symptoms and activity patterns will be monitored with an in-home sensor system before and after deep brain stimulation (DBS), and the above mentioned procedures will be repeated in a longitudinal design.

Official Title
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Objective Assessment of Behavioural Disorders in Parkinson's Disease

Conditions
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Parkinson's Disease, Non-motor Symptoms

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with Parkinson's disease. Able to understand instructions and provide informed consent. Native speaking or proficient French or German Montreal Cognitive Assessment (MoCA) with score ≥ 22 Ability to manipulate handheld dynamometers For sensor part only: planned DBS-surgery Exclusion Criteria: Disease affecting the brain other than Parkinson's disease Suffering from or diagnosed with ongoing psychiatric illnesses Severe somatic illnesses leading to reduced life expectancy Severe physical disability leading to impairment in basic functional activities Participation in a pharmacological study Inability to provide informed consent (legal guardianship)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PD patients with apathy<br>PD patients with apathy according to the diagnostic criteria by Robert et al. 2018 | |
| PD patients with impulse control disorder<br>PD patients with a) at least one item >2 or b) at least two items >1 on the hyperdopaminergic subscale of the Ardouin Scale of Behaviour in Parkinson's Disease | |
| PD patients without any relevant neuropsychiatric symptoms<br>PD patients with a score <2 on each item of the Ardouin Scale of Behaviour in Parkinson's Disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance in an effort-based decision making task (Apple Tree Paradigm) | Decision (yes/no) | Visit 1 (only visit for most patients; for DBS patients 1-3 months before DBS-surgery) | 
| Performance in an effort-based decision making task (Apple Tree Paradigm) | Decision (yes/no) | Visit 2 (only for DBS patients; 4-6 months after DBS-surgery) | 
| Performance in an effort-based decision making task (Apple Tree Paradigm) | Decision (yes/no) | Visit 3 (only for DBS patients; 11-13 months after DBS-surgery) | 
| Performance in a reward task | Pupil diameter (in mm) | Visit 1 (only visit for most patients; for DBS patients 1-3 months before DBS-surgery) | 
| Performance in a reward task | Pupil diameter (in mm) | Visit 2 (only for DBS patients; 4-6 months after DBS-surgery) | 
| Performance in a reward task | Pupil diameter (in mm) | Visit 3 (only for DBS patients; 11-13 months after DBS-surgery) | 
| Performance in an emotion processing task | Pupil diameter (in mm) | Visit 1 (only visit for most patients; for DBS patients 1-3 months before DBS-surgery) | 
| Performance in an emotion processing task | Pupil diameter (in mm) | Visit 2 (only for DBS patients; 4-6 months after DBS-surgery) | 
| Performance in an emotion processing task | Pupil diameter (in mm) | Visit 3 (only for DBS patients; 11-13 months after DBS-surgery) | 
| Change in overall activity from Baseline to 12 months after DBS-surgery | Changes in overall activity patterns related to motivated behaviours (measured in minutes per day) will be deducted from collected from in-home sensor data using signal processing and machine learning algorithms | In-home sensor measurements will be collected from 1-3 months before DBS-surgery until 12 months after DBS-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, Non-motor symptoms, Assessment of non-motor symptoms, Sensor monitoring, Behavioural disorders, Deep Brain Stimulation, Apathy, Impulse Control Disorder