Clinical trial NCT04611581: Objective Assessment of Behavioural Disorders in PD
Official title: Objective Assessment of Behavioural Disorders in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Parkinson's Disease
Non-motor Symptoms
Keywords: Parkinson's Disease
Non-motor symptoms
Assessment of non-motor symptoms
Sensor monitoring
Behavioural disorders
Deep Brain Stimulation
Apathy
Impulse Control Disorder
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
name: University of Oxford
First posted: 2020-11-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with idiopathic Parkinson's disease, treated at the movement disorders clinic in the University Hospital of Bern, Switzerland.

Brief summary: 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: 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 with STN-DBS in an objective way, with the ultimate goal of improving the management of PD patients with STN-DBS.

To do so, the investigators will use three computer-based tasks that measure effort-based decision making 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 STN-DBS, and the above mentioned procedures will be repeated 4 months after STN-DBS.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Parkinson's disease.
* (Planned) STN-DBS.
* 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

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)

Primary outcomes:
measure: Performance in an effort-based decision making task (Apple Tree Paradigm)
timeFrame: Visit 1 (only visit for most patients; for DBS patients 1-3 months before DBS-surgery)
measure: Performance in an effort-based decision making task (Apple Tree Paradigm)
timeFrame: Visit 2 (only for DBS patients; 4-6 months after DBS-surgery)
measure: Performance in an emotion processing task
timeFrame: Visit 1 (only visit for most patients; for DBS patients 1-3 months before DBS-surgery)
measure: Performance in an emotion processing task
timeFrame: Visit 2 (only for DBS patients; 4-6 months after DBS-surgery)
measure: Change in overall activity from Baseline to 4 months after DBS-surgery
timeFrame: In-home sensor measurements will be collected from 1-3 months before DBS-surgery and 4 months after DBS-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Insel Gruppe AG University Hospital of Bern
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Paul Krack, MD
role: PRINCIPAL_INVESTIGATOR
References: